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Cardiovascular
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Miscellaneous
Miscellaneous
QOD
Extracorporeal Circuit And Accessories For Long Term Respiratory Cariodpulmonary Failure
N
Product Code
QRJ
Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
2
Product Code
KPK
Marker, Ostia, Aorto-Saphenous Vein
2
Product Code
DSQ
Ventricular (Assist) Bypass
3
Product Code
FZC
Prosthesis, Arterial Graft, Bovine Carotid Artery
3
Product Code
LOT
Pulse-Generator, Program Module
3
Product Code
LOZ
Artificial Heart
3
Product Code
LPA
System, Esophageal Pacing
3
Product Code
LPB
Cardiac Ablation Percutaneous Catheter
3
Product Code
LPC
Device, Angioplasty, Laser, Coronary
3
Product Code
LWO
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
3
Product Code
LWP
Implantable Pulse Generator, Pacemaker (Non-Crt)
3
Product Code
LWQ
Heart-Valve, Mechanical
3
Product Code
LWR
Heart-Valve, Non-Allograft Tissue
3
Product Code
LWS
Implantable Cardioverter Defibrillator (Non-Crt)
3
Product Code
LWT
Occluder, Balloon, Vena-Cava
3
Product Code
LWW
Pulse-Generator, Single Chamber, Single
3
Product Code
LWX
Device. Laser Peripheral Angioplasty
3
Product Code
LWZ
Tissue Graft Of Less Than 6mm
3
Product Code
LXA
Tissue Graft Of 6mm And Greater
3
Product Code
MAD
Catheter, Percutaneous (Valvuloplasty)
3
Product Code
MAE
Occluder, Patent Ductus, Arteriosus
3
Product Code
MAF
Stent, Coronary
3
Product Code
MCX
Catheter, Coronary, Atherectomy
3
Product Code
MFA
Device, Removal, Pacemaker Electrode, Percutaneous
3
Product Code
MGB
Device, Hemostasis, Vascular
3
Product Code
MIE
Heart-Valve, Allograft
3
Product Code
MIH
System, Endovascular Graft, Aortic Aneurysm Treatment
3
Product Code
MIR
Shunt, Portosystemic, Endoprosthesis
3
Product Code
MLV
Transcatheter Septal Occluder
3
Product Code
MNO
System, Laser, Transmyocardial Revascularization
3
Product Code
MOM
System, Hemodynamic, Implantable
3
Product Code
MOU
Intravascular Radiation Delivery System
3
Product Code
MRM
Defibrillator, Implantable, Dual-Chamber
3
Product Code
MTE
System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
3
Product Code
MUQ
Glue, Surgical, Arteries
3
Product Code
MVK
Wearable Automated External Defibrillator
3
Product Code
MWG
System, Oxygen, Aqueous
3
Product Code
MWH
Pulmonic Valved Conduit
F
Product Code
NAP
Cardiac Support Mesh Wrap
N
Product Code
NAV
Graft, Bypass, Coronary Artery
F
Product Code
NGV
System, Appendage Closure, Left Atrial
3
Product Code
NIK
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
3
Product Code
NIM
Stent, Carotid
3
Product Code
NIN
Stent, Renal
3
Product Code
NIO
Stent, Iliac
3
Product Code
NIP
Stent, Superficial Femoral Artery
3
Product Code
NIQ
Coronary Drug-Eluting Stent
3
Product Code
NIU
Stent, Superficial Femoral Artery, Drug-Eluting
3
Product Code
NIV
Coronary Covered Stent
F
Product Code
NKE
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
3
Product Code
NKM
Mitral Valve Repair Devices
3
Product Code
NPT
Aortic Valve, Prosthesis, Percutaneously Delivered
3
Product Code
NPU
Prosthesis, Mitral Valve, Percutaneously Delivered
3
Product Code
NPV
Pulmonary Valve Prosthesis Percutaneously Delivered
F
Product Code
NVN
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
3
Product Code
P
13
0010
VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)
APPR
PMA Approval
P
03
0036
MEDTRONIC SELECTSECURE LEAD MODEL 3830
APPR
PMA Approval
P
02
0030
STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD
APPR
PMA Approval
P
96
0006
SWEET TIP(R) RX STEROID ELUTING LEAD
APPR
PMA Approval
P
96
0030
PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS
APPR
PMA Approval
P
96
0013
TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS
APPR
PMA Approval
P
96
0004
THINLINE ENDOCARDIAL PACING LEADS
APPR
PMA Approval
P
95
0024
MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
APPR
PMA Approval
P
95
0001
SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
APPR
PMA Approval
P
93
0039
MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568
APPR
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
3
PMA Approval
P
93
0039
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
96
0004
Ventak Av Aicd Ventak Prizm Dr/Vr, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defribillator System
3
PMA Approval
P
96
0006
Sweet Tip (R) Rx Steroid Eluting Lead
3
PMA Approval
P
96
0004
Thinline Endocardial Pacing Leads
3
PMA Approval
P
93
0039
CapSureFix Novus Lead Models 4076 and 5076
3
PMA Approval
P
93
0039
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
96
0004
FNLN2 SXP BP, FNLN2 SXP PF BP, FNLN2 SX PF BP, FNLN2 SXP J BP,
3
PMA Approval
P
96
0004
THINLINE / FINELINE Family of Endocardial Pacing Leads
3
PMA Approval
P
96
0006
SWEET TIP Rx, SWEET PICOTIP Rx, and FLEXTEND
3
PMA Approval
P
93
0039
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure Z Novus Lead
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
3
PMA Approval
P
93
0039
CapSureFix Lead
3
PMA Approval
P
03
0036
Anchoring Sleeve Kit, SelectSecure Lead
3
PMA Approval
P
96
0013
Tendril STS, Tendril ST, Optisense
3
PMA Approval
P
83
0061
CapSure Sense Lead, Vitatron Crystalline Lead
3
PMA Approval
P
96
0030
IsoFlex Optim
3
PMA Approval
P
96
0013
Tendril SDX Lead, Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional)
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, Vitatron Excellence PS+ Lead
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline ActFix Lead, Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
93
0039
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
93
0039
CapSureFix Novus Lead
3
PMA Approval
P
96
0006
SWEET TIP(R) RX STEROID ELUTING LEAD
3
PMA Approval
P
96
0004
THINLINE ENDOCARDIAL PACING LEADS
3
PMA Approval
P
93
0039
CapSureFix Novus Lead
3
PMA Approval
P
96
0013
Tendril ST Lead, OptiSense, Tendril STS Lead and Tendril STS Lead (MR Conditional)
3
PMA Approval
P
96
0030
IsoFlex Optim
3
PMA Approval
P
96
0006
SWEET TIP Rx, SWEET PICOTIO Rx, and FLEXTEND
3
PMA Approval
P
96
0004
THINLINE/FINELINE Family of Endocardial Pacing Leads
3
PMA Approval
P
95
0001
SELUTE Lead System
3
PMA Approval
P
93
0039
CapSureFix Novus Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead
3
PMA Approval
P
96
0030
IsoFlex
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
96
0006
FLEXTEND® Bipolar, Steroid Eluting, Extendable/Retractable Pacing Lead
3
PMA Approval
P
96
0004
FINELINE™ II Sterox, Endocardial Pacing Lead, Passive Fixation
3
PMA Approval
P
83
0061
CapSure Sense Lead
3
PMA Approval
P
93
0039
CapSureFix Novus Lead
3
PMA Approval
P
96
0013
Tendril STS
3
PMA Approval
P
96
0030
IsoFlex Optim, Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional)
3
PMA Approval
P
96
0013
Tendril DX Endocardial Pacing Leads
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
03
0036
Anchoring Sleeve Kit and SelectSecure Lead
3
PMA Approval
P
83
0061
Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Stylet Kit and Vitatron Crystalline Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Stylet Kit, Vitatron Impulse II Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
93
0039
CapSureFix Novus Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead
3
PMA Approval
P
93
0039
CapSureFix Novus Lead
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Excellence SS+ Lead, and Vitatron Impulse II Le
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead, and Vitatron Pirouet Lead
3
PMA Approval
P
03
0036
Anchoring Sleeve Kit and SelectSecure Lead
3
PMA Approval
P
83
0061
Adhesive, CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, and Vitatron Excellence + Lead
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, and Vitatron Impulse II Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, and Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, and Vitatron Crystalline Lead
3
PMA Approval
P
96
0030
IsoFlex Optim
3
PMA Approval
P
96
0013
Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional)
3
PMA Approval
P
93
0039
CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
96
0030
Isoflex
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline ActFix Lead, and Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead and Vitatron Crystalline Lead
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
96
0004
FINELINE II Steroid-Eluting Pacing Leads
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, and Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, and Vitatron Crystalline Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead
3
PMA Approval
P
03
0036
Anchoring Sleeve Kit and SelectSecure Lead
3
PMA Approval
P
03
0036
Anchoring Sleeve Kit, SelectSecure Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
3
PMA Approval
P
93
0039
CapSureFix Novus Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead
3
PMA Approval
P
96
0030
Isoflex
3
PMA Approval
P
96
0013
Tendril SDX, OptiSense, Tendril STS, Tendril ST
3
PMA Approval
P
96
0013
OptiSense Steroid Eluting Cardiac Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
93
0039
CapSureFix Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
83
0061
STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING
3
PMA Approval
P
03
0036
MEDTRONIC SELECTSECURE LEAD MODEL 3830
3
PMA Approval
P
93
0039
MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568
3
PMA Approval
P
83
0061
CapSure Sense Lead
3
PMA Approval
P
96
0013
Tendril SDX, OptiSense, Tendril STS, and Tendril ST
3
PMA Approval
P
96
0030
Isoflex
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
3
PMA Approval
P
85
0089
Vitatron Impulse II Lead
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead
3
PMA Approval
P
93
0039
CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
03
0036
Medtronic SelectSecure MRI SureScan Lead
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
96
0013
Tendril ST and Tendril STS Low Voltage Leads
3
PMA Approval
P
93
0039
CapSureFix Novus Lead; Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead; Vitatron Crystalline Lead
3
PMA Approval
P
03
0036
SelectSure Lead
3
PMA Approval
P
93
0039
CapSureFix Novus; Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSUre SP Novus Lead and Vitatron Impulse II Lead
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead
3
PMA Approval
P
93
0039
CapSureFix Novus Lead
3
PMA Approval
P
96
0013
Tendril ST/STS Steroid Eluting Cardiac Leads
3
PMA Approval
P
96
0013
TENDRIL, OPTISENSE
3
PMA Approval
P
96
0030
ISOFLEX
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead
3
PMA Approval
P
83
0061
CapSure Sense Leand and CapSure SP Novus Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
03
0036
SelectSecure MRI SureScan Lead
3
PMA Approval
P
93
0039
CapSureFix Novus Lead
3
PMA Approval
P
96
0004
FineLine II Sterox Leads, Fineline II Sterox EZ Leads, and Suture Sleeve Accessories for FineLine II Leads
3
PMA Approval
P
93
0039
CapSureFix, Novus Lead
3
PMA Approval
P
03
0036
Anchoring Sleeve Kit, SelectSecure Lead
3
PMA Approval
P
95
0024
Capsure Epicardial Pacing Lead
3
PMA Approval
P
83
0061
CapSure Sense, SP Novus; Vitaron Crystalline Lead
3
PMA Approval
P
85
0089
Capsure SP, Z, Novus Lead; Vitatron Impulse II Lead.
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead and VItatron Crystalline Lead
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure Sp Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead
3
PMA Approval
P
93
0039
CapSureFix Novus Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead
3
PMA Approval
P
83
0061
CapSure Sense Leads
3
PMA Approval
P
93
0039
CapSureFix Novus Leads
3
PMA Approval
P
83
0061
CapSure Sense MRI SureScan Lead
3
PMA Approval
P
93
0039
CapSureFix Novus MRI SureScan Lead
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
03
0036
SelectSecure MRI SureScan Lead
3
PMA Approval
P
93
0039
CapSureFix Novus MRI SureScan Lead
3
PMA Approval
P
83
0061
CapSure Sense MRI SureScan Lead
3
PMA Approval
P
96
0006
Accessory Kit Suture Sleeve Stabilizer and Accessory Terminal Pin Fixation Tool
3
PMA Approval
P
96
0004
Accessory Stylet TAPER .014 45CM, .014 52CM, .014 58CM, .016 45CM, .016 52CM, and .016 58CM, Accessory Stylet TAPER .013
3
PMA Approval
P
83
0061
Adhesive, CapSure Sense Lead, CapSure SP Novvus Lead Stylet Kit and Vitatron Crystalline Lead
3
PMA Approval
P
03
0036
Anchoring Sleeve Kit and SelectSecure Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Stylet Kit and Vitatron Impulse II Lead
3
PMA Approval
P
93
0039
CapSureFIx Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
96
0004
Fineline II Sterox, EZ.
3
PMA Approval
P
96
0004
Fineline II Lead Family
3
PMA Approval
P
96
0013
Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps)
3
PMA Approval
P
96
0013
OpticSense, Tendril STS, SDX, ST Low Voltage Active
3
PMA Approval
P
96
0030
IsoFlex Low Voltage Passive
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead
3
PMA Approval
P
96
0013
Tendril STS 2088TC Lead
3
PMA Approval
P
96
0013
Tendril SDX Lead, Tendril ST Lead, OptiSense and Tendril STS Lead
3
PMA Approval
P
96
0030
IsoFlex Optim
3
PMA Approval
P
96
0013
Tendril SDX, OptiSense, Tendril STS and Tendril ST Low Voltage Active Fixation Leads
3
PMA Approval
P
96
0030
Isoflex Low Voltage Passive Fixation Leads
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
03
0036
Anchoring Sleeve Kit
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, SP Novus Lead; Vitron Crystalline Lead
3
PMA Approval
P
93
0039
CapSureFix Lead, Novus Lead; Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
85
0089
CapSure SP, Z Novus Lead; Vitatron Impulse II Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
03
0036
Anchoring Sleev Kit and SelectSecure LEad
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead and Vitatron Impulse II Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead
3
PMA Approval
P
96
0013
Tendrill SDX, OptiSense, Tendrill STS, Tendril ST.
3
PMA Approval
P
96
0030
Isoflex
3
PMA Approval
P
96
0013
Tendril and OptiSense Low Voltage Leads
3
PMA Approval
P
96
0030
Isoflex Low Voltage Leads
3
PMA Approval
P
96
0013
Tendril SDX Lead, Tendril ST Lead, OptiSense, Tendril STS Lead
3
PMA Approval
P
96
0030
IsoFlex Optim
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, and Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure Z Novus Lead, and Vitatron Impulse II Lead
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
96
0004
FINELINE II Sterox Lead, FINELINE II Sterox EZ Lead abnd Suture Sleeve Accessory (for FINELINE II Leads)
3
PMA Approval
P
96
0004
Fineline II
3
PMA Approval
P
96
0006
Flextend
3
PMA Approval
P
96
0013
Tendril SDX, OptiSense, Tendril STS and Tendril ST
3
PMA Approval
P
96
0030
IsoFlex
3
PMA Approval
P
83
0061
CapSure Sense Lead; CapSure SP Novus Lead; Vitatron Crystalline Lead
3
PMA Approval
P
93
0039
CapSureFix Lead; CapSureFix Novus Lead; Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead; CapSure SP Z Lead; CapSure SP Z Novus; CapSure SP Z Lead; CapSure Z Novus Lead; Vitatron Impulse
3
PMA Approval
P
85
0089
Vitatron Excellence SS+ Lead
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
93
0039
Vitatron Crystalline Active Fixation Lead and Vitatron Pirouet Lead
3
PMA Approval
P
83
0061
Vitatron Crystalline Lead and Vitatron Excellence + Lead
3
PMA Approval
P
93
0039
CapSureFix Novus MRi SureScan Lead and CapSureFix Novus MRI SureScan Lead
3
PMA Approval
P
03
0036
SelectSecure MRI SureScan Lead
3
PMA Approval
P
83
0061
CapSure Sense MRI SureScan Lead and CapSure Sense MRI SureScan Lead
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
3
PMA Approval
P
03
0036
Anchoring Sleeve Kit, SelectSecure Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
83
0061
Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead
3
PMA Approval
P
93
0039
CapSureFix Novus Lead
3
PMA Approval
P
96
0004
Fineline ll Lead Family
3
PMA Approval
P
96
0006
Sweet Tip(R) RX Steroid Eluting Lead
3
PMA Approval
P
96
0004
Thinline Endocardial Pacing Leads
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, and VItatron Crystalline Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
3
PMA Approval
P
93
0039
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
93
0039
CapSure Fix Novus Lead; Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
96
0030
IsoFlex Optim Leads (lV Passive)
3
PMA Approval
P
96
0013
Tendril SDX/ST/STS and Optisense Leads (LV Active)
3
PMA Approval
P
96
0013
Tendril SDX, OptiSense, Tendril STS, Tendril ST
3
PMA Approval
P
96
0030
IsoFlex
3
PMA Approval
P
96
0030
IsoFlex
3
PMA Approval
P
96
0013
OptiSense; Tendril STS, Tendril SDX, Tendril ST
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead, and Vitatron Pirouet Lead
3
PMA Approval
P
85
0089
CapSure SP and Z Novus Lead, Vitatron Excellence SS+ Lead and Vitatron Impulse II Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
03
0036
Anchoring Sleeve Kit and SelectSecure Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, and Vitatron Excellence + Lead
3
PMA Approval
P
03
0036
SelectSecure MRI SureScan Lead
3
PMA Approval
P
83
0061
CapSure Sense MRI SureScan Lead
3
PMA Approval
P
93
0039
CapSureFix Novus MRI SureScan Lead
3
PMA Approval
P
96
0030
IsoFlex Optim
3
PMA Approval
P
96
0013
Tendril SDX Lead, Tendril ST Lead, OptiSense, Tentril STS Lead
3
PMA Approval
P
96
0013
Tendril and Optisense f Low Voltage Leads
3
PMA Approval
P
96
0030
Isoflex Low Voltage Lead
3
PMA Approval
P
96
0004
FINELINE II Lead Family
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active, Fixation Lead
3
PMA Approval
P
96
0013
Tendril ST; Tendril STS; Optisense
3
PMA Approval
P
85
0089
CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
3
PMA Approval
P
93
0039
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
93
0039
CapSure Fix Novus Lead (4076, 5076)
3
PMA Approval
P
83
0061
CapSure Sense Lead (4074, 4574)
3
PMA Approval
P
96
0004
FINELINE™ II Sterox Leads, Suture Sleeve Accessory for FINELINE II Leads, (Pacing Leads and Accessories)
3
PMA Approval
P
83
0061
CapSure Sense Lead/CapSure SP Novus Lead/CapSureSense Lead/Vitatron Crystalline Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
03
0036
SelectSecure Lead
3
PMA Approval
P
93
0039
CapSureFix Lead/CapSureFix Novus Lead/Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead/CapSure SP Z Lead/CapSure Z Novus Lead/Vitatron Impulse II Lead
3
PMA Approval
P
03
0036
SelectSecure MRI SureScan Lead
3
PMA Approval
P
93
0039
CapSureFix Novus MRI SureScan Lead
3
PMA Approval
P
83
0061
CapSure Sense MRI SureScan Lead
3
PMA Approval
P
03
0036
SelectSecure MRI SureScan Lead
3
PMA Approval
P
83
0061
CapSureFix Novus MRI SureScan Lead (4074 and 4574)
3
PMA Approval
P
93
0039
CapSureFix Novus MRI SureScan Lead
3
PMA Approval
P
93
0039
CapSureFix Lead/ CapSureFix Novus Lead/ Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead/ CapSure SP Novus Lead/Vitatron Crystalline Lead
3
PMA Approval
P
85
0089
CapSure SP Novus Lead/ CapSure SP Z Lead/ CapSure Z Novus Lead/ Vitatron Impulse II Lead
3
PMA Approval
P
93
0039
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation/Pirouet Lead
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
3
PMA Approval
P
85
0089
CapSure SP/Z Novus Lead, Vitatron Excellence SS+/Impulse II Lead
3
PMA Approval
P
93
0039
CapSureFix Novus Lead 4076, 5076 - Vitatron Crystalline Active Fixation Lead ICF09, ICF09B, ICFQ09B
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
93
0039
CapSureFix/CapSureFix Novus/Vitatron Crystalline Active Fixation Lead
3
PMA Approval
P
83
0061
CapSure Sense/CapSure SP/CapSure SP Novus/CapSureSense/Vitatron Crystalline Lead
3
PMA Approval
P
85
0089
CapSure SP Novus/CapSure SP Z/CapSure Z Novus/Vitatron Impulse II Lead
3
PMA Approval
P
96
0004
Fineline II Sterox and Sterox EZ Lead
3
PMA Approval
P
83
0061
CAPSURE SENSE MRI SURESCAN LEAD
3
PMA Approval
P
83
0061
CAPSURE SENSE MRI SURESCAN LEAD
3
PMA Approval
P
93
0039
CAPSUREFIX NOVUS MRI SURESCAN LEAD
3
PMA Approval
P
03
0036
SELECTSECURE LEAD MODEL 3830
3
PMA Approval
P
03
0036
SELECTSECURE MRI SURESCAN LEAD
3
PMA Approval
P
93
0039
CAPSUREFIX NOVUS MRI SURESCAN LEAD
3
PMA Approval
P
83
0061
CAPSURE SENSE MRI SURESCAN LEAD MODEL 4574
3
PMA Approval
P
03
0036
SELECTSECURE MRI SURESCAN LEAD MODEL 3830
3
PMA Approval
P
93
0039
CAPSURE FIX NOVUS MRI SURESCAN LEAD MODELS 5076 AND 4076
3
PMA Approval
P
93
0039
CapSureFix Novus MRI SureScan Lead
3
PMA Approval
P
83
0061
CapSure Sense MRI SureScan Leads
3
PMA Approval
P
03
0036
MEDTRONIC SELECTSECURE LEAD MODEL 3830
3
PMA Approval
P
96
0004
FINELINE II Sterox and Sterox EZ Lead
3
PMA Approval
P
96
0004
FINELINE II STEROX & FINELINE II STEROX EZ, SUTURE SLEEVE ACCESSORY(FOR FINELINE II LEADS)
3
PMA Approval
P
96
0013
Tendril SDX Lead, Tendril ST Lead, OptiSence, Tendril STS Lead
3
PMA Approval
P
96
0030
IsoFlex Optim
3
PMA Approval
P
96
0030
IsoFlex Optim leads (LV Passive)
3
PMA Approval
P
96
0013
Tendril SDX/ST/STS and optisense leads (LV active)
3
PMA Approval
P
96
0013
Tendril SDX/ST/STS and Optisense leads (LV Active)
3
PMA Approval
P
96
0030
IsoFlex Optim leads (LV Passive)
3
PMA Approval
P
96
0030
ISOFLEX OPTIM LEADS (LV PASSIVE)
3
PMA Approval
P
96
0013
TENDRIL SDX/ST/STS AND OPTISENSE LEADS (LV ACTIVE)
3
PMA Approval
P
93
0039
CAPSUREFIX NOVUS LEAD ; VITATRON CRYSTALLLINE ACTIVE FIXATION LEAD
3
PMA Approval
P
85
0089
CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS
3
PMA Approval
P
83
0061
CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD
3
PMA Approval
P
95
0024
MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
3
PMA Approval
P
96
0030
IsoFlex Optim leads
3
PMA Approval
P
96
0013
Tendril SDX, Tendril ST, Tendril STS and Optisense leads
3
PMA Approval
P
96
0030
ISOFLEX OPTIM LEADS (LV PASSIVE)
3
PMA Approval
P
96
0013
TENDRIL SDX, TENDRIL ST, TENDRIL STS AND OPTISENSE LEADS (LV ACTIVE)
3
PMA Approval
P
03
0036
SELECTSECURE LEAD
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
85
0089
CAPSURE SP NOVUS LEAD / Z LEAD ; CAPSURE Z NOVUS LEAD ; VITATRON IMPLUSE II LEAD
3
PMA Approval
P
93
0039
CAPSUREFIX LEAD; CAPSUREFIX NOVUS LEAD; VITATRON CRYSTALLINE ACTIVE FIXATION LEAD
3
PMA Approval
P
83
0061
CAPSURE SENSE LEAD /SP LEAD / CAPSURE SP NOVUS LEAD/ VITATRON CRYSTALLINE LEAD/ VITATRON EXCELLENCE PS + LEAD
3
PMA Approval
P
83
0061
ADHESIVE, CAPSURE SENSE LEAD, CAPSURE SP LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE AND EXCELLENCE PS+ LEAD
3
PMA Approval
P
95
0024
CapSure Epicardial Pacing Lead
3
PMA Approval
P
85
0089
CAPSURE SP NOVUS, CAPSURE SP Z, CAPSURE Z NOVUS, VITATRON IMPULSE II LEAD
3
PMA Approval
P
93
0039
MEDTRONIC(R) CAPSUREFIX LEAD
3
PMA Approval
P
03
0036
MEDTRONIC SELECTSECURE LEAD/ANCHORING SLEEVE KIT
3
PMA Approval
P
96
0030
IsoFlex Optim Leads
3
PMA Approval
P
96
0013
TENDRIL SDX, TENDRIL ST, TENDRIL STS AND OPTISENSE LEADS
3
PMA Approval
P
93
0039
CAPSUREFIX/CAPSUREFIX NOVUS/VITATRON CRYSTALLINE ACTIVE FIXATION LEADS
3
PMA Approval
P
83
0061
ADHESIVE/CAPSURE SENSE/CAPSURE SP NOVUS/VITATRON CRYSTALLINE/VITATRON EXCELLENCE PS+ LEADS
3
PMA Approval
P
85
0089
CAPSURE SP NOVUS/CAPSURE SP Z/CAPSURE Z NOVUS/VITATRON IMPULSE II LEADS
3
PMA Approval
P
95
0024
CAPSURE EPICARDIAL PACING LEAD
3
PMA Approval
P
03
0036
ANCHORING SLEEVE KIT/SELECTSECURE LEAD
3
PMA Approval
P
93
0039
MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568
3
PMA Approval
P
83
0061
CAPSURE SENSE MRI SURESCAN LEAD MODEL 4574
3
PMA Approval
P
93
0039
CapSureFix Novus Lead 4076, 5076
3
PMA Approval
P
93
0039
CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076
3
PMA Approval
P
83
0061
CAPSURE SENSE MRI SURESCAN LEAD MODELS 4074 AND 4574.
3
PMA Approval
P
93
0039
CapSureFix Novus Lead; Vitatron Crystalline; Active Fixation Lead
3
PMA Approval
P
83
0061
CapSure Sense, SP Novus Lead: Vitatron Crystalline, Excellence PS+ Lead;
3
PMA Approval
P
83
0061
CAPSURE SENSE LEAD; CAPSURE SP NOVUS LEAD; VITATRON CYRSTALLINE LEAD; VITATRON EXCELLENCE PS+ LEAD
3
PMA Approval
P
85
0089
CAPSURE SP NOVUS/CAPSURE SP Z/CAPSURE Z NOVUS LEADS, VITATRON IMPULSE II LEAD
3
PMA Approval
P
93
0039
CAPSUREFIX,CAPSUREFIX NOVUS, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD
3
PMA Approval
P
96
0013
TENDRIL ST, STS AND OPTISENSE LV LEADS
3
PMA Approval
P
83
0061
CapSure Sense Lead Models 4074, 4574
3
PMA Approval
P
93
0039
CapSureFix Novus Lead Model 4076
3
PMA Approval
P
83
0061
CapSure Sense Lead; Vitatron Crystalline Lead, ICM09
3
PMA Approval
P
93
0039
CapSure Fix Novus Lead; Vitatron Crystalline Active; Fixation Lead, ICF09, ICQ09B
3
PMA Approval
P
83
0061
Capsure Sense MRI SureScan Lead Model 4074, Capsure Sense MRI SureScan Lead Model 4574
3
PMA Approval
P
93
0039
CapSureFix MRI 4076,CapSureFix Novus MRI 5076, CapSureFix MRI SureScan 5086MRI LEAD MODELS
3
PMA Approval
P
93
0039
CapSureFix Novus Lead
3
PMA Approval
P
93
0039
MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568
3
PMA Approval
P
93
0039
CAPSUREFIX NOVUS LEAD
3
PMA Approval
P
03
0036
SELECTSECURE LEAD
3
PMA Approval
P
96
0004
FINELINE II
3
PMA Approval
P
95
0037
Solia S 45, 53, 60 Siello S 45, 53, 60 Drug-Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Elec
3
PMA Approval
P
96
0013
TENDRIL SDX, TENDRIL ST, TENDRIL STS, OPTISENSE
3
PMA Approval
P
96
0030
ISOFLEX OPTIM
3
PMA Approval
P
93
0039
CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD
3
PMA Approval
P
03
0036
SELECTSECURE LEAD
3
PMA Approval
P
95
0024
CAPSURE EPICARDIAL PACING LEAD
3
PMA Approval
P
85
0089
CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD
3
PMA Approval
P
83
0061
ADHESIVE, CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD
3
PMA Approval
P
95
0001
SELUTE Pacing Lead Family
3
PMA Approval
P
96
0006
SWEET TIP RX, SWEET PICOTIP Rx, and FLEXTEND Pacing Lead Families
3
PMA Approval
P
96
0004
THINLINE/FINELINE Family of ENDOCARDIAL PACING LEADS
3
PMA Approval
P
96
0030
IsoFlex Optim LV leads
3
PMA Approval
P
96
0013
Tendril SDX, ST, STS and OptiSense LV leads
3
PMA Approval
P
96
0004
FINELINE II STEROX AND STEROX EZ LEADS
3
PMA Approval
P
96
0030
IsoFlex 1944, 1948
3
PMA Approval
P
96
0013
Tendril ST 1888/1882 TC; Tendril STS 2088 TC; Optisense 1999
3
PMA Approval
P
96
0013
TENDRIL SDX LEAD, TENDRIL ST LEAD, OPTISENSE, TENDRIL STS LEAD
3
PMA Approval
P
96
0030
ISOFLEX OPTIM
3
PMA Approval
P
93
0039
CapSureFix Novus Lead 5076; Vitatron Crystalline
3
PMA Approval
P
83
0061
CapSure Sense Lead 4074, 4574; CapSure SP Novus Lead 4092, 4592
3
PMA Approval
P
85
0089
CapSure SP Novus Lead 5092, 5592, 5594; CapSure Z Novus Lead 5054, 5554
3
PMA Approval
P
96
0030
IsoFlex Models 1642T, 1646T, 1944, 1948
3
PMA Approval
P
96
0030
ISOFLEX OPTIM LV LEADS
3
PMA Approval
P
96
0004
FINELINE II STEROX IMPLANTABLE CARDIAC ENDOCARDIAL PACING LEADS
3
PMA Approval
P
96
0004
FINELINE II STEROX AND STEROX EZ ENDOCARDIAL PACING LEAD
3
PMA Approval
P
96
0004
FINELINE II STEROX ENDOCARDIAL PACING LOEADS & FINELINE II STEROX EZ ENDOCARDIAL PACING LEADS
3
PMA Approval
P
96
0013
TENDRIL SDX, TENDRIL ST, OPTISENSE, TENDRIL STS FAMILY OF LV LEADS
3
PMA Approval
P
96
0030
ISOFLEX OPTIM FAMILY OF PACING LEADS
3
PMA Approval
P
96
0004
FINELINE II STEROID-ELUTING PACING LEADS, PASSIVE AND ACTIVE FIXATIONS MODELS
3
PMA Approval
P
96
0013
TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS
3
PMA Approval
P
96
0004
FINELINE 2 PACING LEADS
3
PMA Approval
P
96
0004
FINELINE II STEROX ENDOCARDIAL PACING LEAD
3
PMA Approval
P
96
0004
FINELINE II PACE/SENSE LEAD
3
PMA Approval
P
96
0004
FINELINE II STEROID-ELUTING PACING LEADS
3
PMA Approval
P
01
0012
EASY TRAK 2 FAMILY
3
PMA Approval
P
93
0039
MEDTRONIC CAPSUREFIX NOVUS MRI SURESCAN MODEL 5076 LEAD
3
PMA Approval
P
96
0004
THIN/LINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS
3
PMA Approval
P
96
0004
THINLINE AND FINELINE TRANSVENOUS ENDOCARDIAL PACING LEADS
3
PMA Approval
P
96
0004
FINELINE II STEROX
3
PMA Approval
P
96
0030
ISOFLEX FAMILY OF LEADS (1944,1948)
3
PMA Approval
P
96
0013
TENDRIL AND OPTISENSE FAMILY OF LEADS
3
PMA Approval
P
96
0004
THINLINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS
3
PMA Approval
P
96
0004
FINELINE II STEROX LEAD
3
PMA Approval
P
96
0004
FINLINE LEAD FAMILY
3
PMA Approval
P
96
0013
TENDRILL STS MODEL 2088TC LEAD
3
PMA Approval
P
96
0004
THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS
3
PMA Approval
P
95
0024
CAPSURE EPI PACING LEADS
3
PMA Approval
P
95
0024
CAPSURE EPI PACING LEADS
3
PMA Approval
P
96
0004
THINLINE/FINELINE FAMILIES OF PACING LEADS
3
PMA Approval
P
03
0036
MEDTRONIC SELECTSECURE LEAD MODEL 3830
3
PMA Approval
P
96
0013
TENDRIL SDX, TENDRIL ST, TENDRIL STS, OPTISENSE
3
PMA Approval
P
96
0004
THINLINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS AND ACCESSORIES
3
PMA Approval
P
96
0004
THINLINE/FINELINE LEADS FAMILIES
3
PMA Approval
P
96
0004
THINLINE II AND FINELINE II STEROX LEADS AND FINELINE II EZ STEROX LEADS
3
PMA Approval
P
96
0013
TENDRIL FAMILY OF LEADS
3
PMA Approval
P
96
0004
FINELINE 11 AND THINLINE II
3
PMA Approval
P
96
0004
THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS
3
PMA Approval
P
96
0013
TENDRIL (TENDRIL, TENDRIL ST, TENDRIL STS) AND OPTISENSE FAMILY OF LEADS
3
PMA Approval
P
96
0004
THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS
3
PMA Approval
P
96
0030
PASSIVE PLUS AND IOSFLEX LEAD FAMILIES
3
PMA Approval
P
96
0013
TENDRIL AND OPTISENSE LEAD FAMILIES
3
PMA Approval
P
96
0013
CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE
3
PMA Approval
P
96
0004
THINLINE II STEROX, FINELINE II STEROX & FINELINE II STEROX EZ LEADS
3
PMA Approval
P
96
0013
OPTISENSE LEAD MODEL 1999 TUBING
3
PMA Approval
P
96
0013
TENDRIL STS 1988TC AND 2088TC
3
PMA Approval
P
96
0013
TENDRIL FAMILY OF LEADS
3
PMA Approval
P
96
0013
TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS
3
PMA Approval
P
96
0013
TENDRIL STS
3
PMA Approval
P
09
0013
REVO MRI
3
PMA Approval
P
96
0013
TENDRIL/TENDRIL ST & STS/OPTISENSE
3
PMA Approval
P
96
0004
THINLINE/FINELINE FAMILIES
3
PMA Approval
P
96
0013
1782 TENDRIL LEADS
3
PMA Approval
P
03
0036
MEDTRONIC SELECTSECURE LEAD MODEL 3830
3
PMA Approval
P
96
0004
THINLINE II, STEROX, FINELINE II STEROX AND FINELINE II STEROX EZ
3
PMA Approval
P
96
0013
TENDRIL LEADS
3
PMA Approval
P
96
0013
OPTISENSE MODEL 1999 LEAD
3
PMA Approval
P
96
0004
THINLINE/FINELINE
3
PMA Approval
P
96
0013
TENDRIL STS MODELS 2088TC & 1988TC LEADS
3
PMA Approval
P
96
0013
OPTISENSE 1999 LEAD
3
PMA Approval
P
96
0013
TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS
3
PMA Approval
P
96
0013
TENDRIL STS LEAD MODEL 1988TC
3
PMA Approval
P
96
0013
TENDRIL/TENDRIL ST/TENDRIL STS/OPTISENSE LEADS
3
PMA Approval
P
96
0013
TENDRIL LEADS
3
PMA Approval
P
96
0004
THINLINE/FINELINE
3
PMA Approval
P
96
0004
THINLINE II STEROX/THINLINE II STEROX/EZ/FINELINE II STEROX/EZ/TAPERED STYLET
3
PMA Approval
P
96
0013
TENDRIL LEADS
3
PMA Approval
P
96
0013
OPTISENSE RIGHT ATRIAL LEAD
3
PMA Approval
P
96
0013
TENDRIL/TENDRIL ST & OPTISENSE FAMILIES OF LEADS
3
PMA Approval
P
96
0013
TENDRIL 1888 LEADS
3
PMA Approval
P
96
0013
TENDRIL 1888 LEAD
3
PMA Approval
P
96
0013
TENDRIL ST LEAD MODEL 1882 LEADS
3
PMA Approval
P
96
0013
TENDRIL/TENDRIL ST/OPTISENSE LEADS
3
PMA Approval
P
96
0004
FINELINE II/THINLINE II BRADY LEADS
3
PMA Approval
P
96
0013
TENDRIL STS LEAD MODEL 2088TC
3
PMA Approval
P
96
0013
ST JUDE MEDICAL TENDRIL ST MODEL 1888 LEAD
3
PMA Approval
P
96
0004
FINELINE II STEROX EZ LEADS
3
PMA Approval
P
03
0036
MEDTRONIC SELECTSECURE LEAD MODEL 3830
3
PMA Approval
P
02
0030
STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD
3
PMA Approval
P
96
0006
SWEET TIP(R) RX STEROID ELUTING LEAD
3
PMA Approval
P
96
0030
PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS
3
PMA Approval
P
96
0013
TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS
3
PMA Approval
P
96
0004
THINLINE ENDOCARDIAL PACING LEADS
3
PMA Approval
P
95
0024
MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
3
PMA Approval
P
95
0001
SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
3
PMA Approval
P
93
0039
MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568
3
PMA Approval
P
85
0089
CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS
3
PMA Approval
P
83
0061
STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING
3
PMA Approval
NVY
Permanent Defibrillator Electrodes
3
Product Code
NVZ
Pulse Generator, Permanent, Implantable
3
Product Code
NWX
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
3
Product Code
OAD
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
3
Product Code
OAE
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
3
Product Code
OBC
Occluder, Internal Vessel, Temporary
3
Product Code
OBD
Barrier, Adhesion, Cardiovascular
3
Product Code
OCM
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
3
Product Code
ODT
Tissue Adhesive, Aortic Aneurysmorrhaphy
F
Product Code
OHA
Heart Valve, More Than Minimally Manipulated Allograft
U
Product Code
OJE
Right Ventricular Bypass (Assist) Device
F
Product Code
OJX
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
3
Product Code
ONU
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
3
Product Code
OSR
Pacemaker/Icd/Crt Non-Implanted Components
3
Product Code
OZD
Temporary Non-Roller Type Left Heart Support Blood Pump
3
Product Code
OZG
Transcatheter Septal Occluder (Atrial)
3
Product Code
OZH
Transcatheter Septal Occluder (Ventricular)
3
Product Code
PAP
Aortic Heart Valve, More Than Minimally Manipulated Allograft
F
Product Code
PCW
Implantable Pulse Generator, Programmer And Battery Charger
N
Product Code
PCX
Artificial Chordae Tendinae Delivery System
N
Product Code
PFV
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
3
Product Code
PIZ
Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve
3
Product Code
PJQ
Agent, Occluding, Vascular, Permanent
3
Product Code
PKK
Stent Delivery System
N
Product Code
PNF
Aortic Stent
3
Product Code
PNY
Absorbable Coronary Drug-Eluting Stent
3
Product Code
PRC
Drug-Coated Peripheral Transluminal Angioplasty Catheter
3
Product Code
PRL
Iliac Covered Stent, Arterial
3
Product Code
QAN
Stent, Iliac Vein
3
Product Code
QBI
Acute Coronary Syndrome Event Detector
3
Product Code
QCT
Scaffold, Dissection Repair
3
Product Code
QFV
Implantable Pulse Generator
3
Product Code
QLJ
Patient Monitor With Independent Remote Display And Operation
N
Product Code
QLL
Left Ventricular Ejection Fraction Screening Tool
N
Product Code
QLM
Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool
N
Product Code
QLN
Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19
N
Product Code
QMG
Shockwave Intravascular Lithotripsy System
3
Product Code
QNY
Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring
N
Product Code
QNZ
Powered Communication System For Emergency Use
N
Product Code
QOA
Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening
N
Product Code
QOC
Temporary Non-Roller Type Left Or Right Heart Support Blood Pump
N
Product Code
QIK
Organ Care System (Ocs) Heart System
3
Product Code
QSK
Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
3
Product Code
QWA
Cardiovascular Delivery Catheter System Positioning And Stabilization Device
1
Product Code
QWM
Stent Graft, Bypass, Superficial Femoral Artery
3
Product Code
QXO
Cardiovascular Machine Learning-Based Notification Software
2
Product Code
QWC
Pulmonary Stent
3
Product Code
QVQ
Extravascular Support For An Arteriovenous Fistula For Vascular Access
3
Product Code
QXV
Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
2
Product Code
QWN
Stent Graft, Infrapopliteal, Venous Arterialization
3
Product Code
QXU
Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
2
Product Code
QXX
Coronary Artery Disease Machine Learning-Based Notification Software
2
Product Code
QYE
Reduced Ejection Fraction Machine Learning-Based Notification Software
2
Product Code
QVG
Embolization Agent, Vascular
3
Product Code
QYI
Ablation Catheter, Renal Denervation
3
Product Code
QYU
Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
2
Product Code
QZI
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
3
Product Code
QZK
Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions
3
Product Code
QZU
Temporary Embolization Assist Device, Peripheral
2
Product Code
NPW
Percutaneously Delivered Prostheses And Tricuspid Valves
3
Product Code
OOB
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
3
Product Code
NPS
Tricuspid Valve Repair Device, Percutaneously Delivered
3
Product Code
SAT
Pulmonary Hypertension Machine Learning-Based Notification Software
2
Product Code
SBK
Artificial Chordae Tendineae Surgical Replacement System
2
Product Code
SBQ
Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
2
Product Code
QXY
Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification
2
Product Code
SCZ
Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
2
Product Code
NXW
Scaffold, Infrapopliteal, Absorbable
3
Product Code
SEG
Leadless Cardiac Resynchronization Therapy (Crt)
3
Product Code
SEU
Peripheral Temporary And Retrievable Stent System
2
Product Code
SFR
Hypertension Machine Learning-Based Notification Software
2
Product Code
QKJ
Stent, Central Venous
3
Product Code
SEQ
Covered Stent Vascular Connector, Hemodialysis Access Circuit
3
Product Code
SGO
Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
2
Product Code
Submissions with No Product Code
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
Subpart E—Cardiovascular Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
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Ear, Nose, Throat
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Gastroenterology and Urology
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Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
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Orthopedic
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Last synced on 25 January 2026 at 3:41 am
CV
/
CV-misc
/
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P090013
View Source
REVO MRI
Page Type
PMA Approval
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Medtronic, Inc
Trade Name
REVO MRI SURESCAN IPG AND PACING SYSTEM
Generic Name
Implantable pulse generator, pacemaker (non-CRT)
Decision Date
2/8/2011
Days to Decision
609 days
Decision Code
APPR
FDA Decision
Approval
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Miscellaneous
QOD
Extracorporeal Circuit And Accessories For Long Term Respiratory Cariodpulmonary Failure
QRJ
Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
KPK
Marker, Ostia, Aorto-Saphenous Vein
DSQ
Ventricular (Assist) Bypass
FZC
Prosthesis, Arterial Graft, Bovine Carotid Artery
LOT
Pulse-Generator, Program Module
LOZ
Artificial Heart
LPA
System, Esophageal Pacing
LPB
Cardiac Ablation Percutaneous Catheter
LPC
Device, Angioplasty, Laser, Coronary
LWO
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
LWP
Implantable Pulse Generator, Pacemaker (Non-Crt)
LWQ
Heart-Valve, Mechanical
LWR
Heart-Valve, Non-Allograft Tissue
LWS
Implantable Cardioverter Defibrillator (Non-Crt)
LWT
Occluder, Balloon, Vena-Cava
LWW
Pulse-Generator, Single Chamber, Single
LWX
Device. Laser Peripheral Angioplasty
LWZ
Tissue Graft Of Less Than 6mm
LXA
Tissue Graft Of 6mm And Greater
MAD
Catheter, Percutaneous (Valvuloplasty)
MAE
Occluder, Patent Ductus, Arteriosus
MAF
Stent, Coronary
MCX
Catheter, Coronary, Atherectomy
MFA
Device, Removal, Pacemaker Electrode, Percutaneous
MGB
Device, Hemostasis, Vascular
MIE
Heart-Valve, Allograft
MIH
System, Endovascular Graft, Aortic Aneurysm Treatment
MIR
Shunt, Portosystemic, Endoprosthesis
MLV
Transcatheter Septal Occluder
MNO
System, Laser, Transmyocardial Revascularization
MOM
System, Hemodynamic, Implantable
MOU
Intravascular Radiation Delivery System
MRM
Defibrillator, Implantable, Dual-Chamber
MTE
System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
MUQ
Glue, Surgical, Arteries
MVK
Wearable Automated External Defibrillator
MWG
System, Oxygen, Aqueous
MWH
Pulmonic Valved Conduit
NAP
Cardiac Support Mesh Wrap
NAV
Graft, Bypass, Coronary Artery
NGV
System, Appendage Closure, Left Atrial
NIK
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
NIM
Stent, Carotid
NIN
Stent, Renal
NIO
Stent, Iliac
NIP
Stent, Superficial Femoral Artery
NIQ
Coronary Drug-Eluting Stent
NIU
Stent, Superficial Femoral Artery, Drug-Eluting
NIV
Coronary Covered Stent
NKE
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
NKM
Mitral Valve Repair Devices
NPT
Aortic Valve, Prosthesis, Percutaneously Delivered
NPU
Prosthesis, Mitral Valve, Percutaneously Delivered
NPV
Pulmonary Valve Prosthesis Percutaneously Delivered
NVN
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
P
13
0010
VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)
P
03
0036
MEDTRONIC SELECTSECURE LEAD MODEL 3830
P
02
0030
STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD
P
96
0006
SWEET TIP(R) RX STEROID ELUTING LEAD
P
96
0030
PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS
P
96
0013
TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS
P
96
0004
THINLINE ENDOCARDIAL PACING LEADS
P
95
0024
MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
P
95
0001
SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
P
93
0039
MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
P
93
0039
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
P
85
0089
CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
96
0004
Ventak Av Aicd Ventak Prizm Dr/Vr, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defribillator System
P
96
0006
Sweet Tip (R) Rx Steroid Eluting Lead
P
96
0004
Thinline Endocardial Pacing Leads
P
93
0039
CapSureFix Novus Lead Models 4076 and 5076
P
93
0039
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
P
96
0004
FNLN2 SXP BP, FNLN2 SXP PF BP, FNLN2 SX PF BP, FNLN2 SXP J BP,
P
96
0004
THINLINE / FINELINE Family of Endocardial Pacing Leads
P
96
0006
SWEET TIP Rx, SWEET PICOTIP Rx, and FLEXTEND
P
93
0039
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
P
85
0089
CapSure SP Novus Lead, CapSure Z Novus Lead
P
03
0036
SelectSecure Lead
P
83
0061
CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
P
93
0039
CapSureFix Lead
P
03
0036
Anchoring Sleeve Kit, SelectSecure Lead
P
96
0013
Tendril STS, Tendril ST, Optisense
P
83
0061
CapSure Sense Lead, Vitatron Crystalline Lead
P
96
0030
IsoFlex Optim
P
96
0013
Tendril SDX Lead, Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional)
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, Vitatron Excellence PS+ Lead
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline ActFix Lead, Vitatron Crystalline Active Fixation Lead
P
93
0039
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
P
93
0039
CapSureFix Novus Lead
P
96
0006
SWEET TIP(R) RX STEROID ELUTING LEAD
P
96
0004
THINLINE ENDOCARDIAL PACING LEADS
P
93
0039
CapSureFix Novus Lead
P
96
0013
Tendril ST Lead, OptiSense, Tendril STS Lead and Tendril STS Lead (MR Conditional)
P
96
0030
IsoFlex Optim
P
96
0006
SWEET TIP Rx, SWEET PICOTIO Rx, and FLEXTEND
P
96
0004
THINLINE/FINELINE Family of Endocardial Pacing Leads
P
95
0001
SELUTE Lead System
P
93
0039
CapSureFix Novus Lead
P
83
0061
CapSure Sense Lead
P
96
0030
IsoFlex
P
03
0036
SelectSecure Lead
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
85
0089
CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
P
03
0036
SelectSecure Lead
P
96
0006
FLEXTEND® Bipolar, Steroid Eluting, Extendable/Retractable Pacing Lead
P
96
0004
FINELINE™ II Sterox, Endocardial Pacing Lead, Passive Fixation
P
83
0061
CapSure Sense Lead
P
93
0039
CapSureFix Novus Lead
P
96
0013
Tendril STS
P
96
0030
IsoFlex Optim, Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional)
P
96
0013
Tendril DX Endocardial Pacing Leads
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
P
03
0036
Anchoring Sleeve Kit and SelectSecure Lead
P
83
0061
Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Stylet Kit and Vitatron Crystalline Lead
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Stylet Kit, Vitatron Impulse II Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
93
0039
CapSureFix Novus Lead
P
83
0061
CapSure Sense Lead
P
83
0061
CapSure Sense Lead
P
93
0039
CapSureFix Novus Lead
P
03
0036
SelectSecure Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Excellence SS+ Lead, and Vitatron Impulse II Le
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead, and Vitatron Pirouet Lead
P
03
0036
Anchoring Sleeve Kit and SelectSecure Lead
P
83
0061
Adhesive, CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, and Vitatron Excellence + Lead
P
03
0036
SelectSecure Lead
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, and Vitatron Impulse II Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, and Vitatron Crystalline Active Fixation Lead
P
03
0036
SelectSecure Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, and Vitatron Crystalline Lead
P
96
0030
IsoFlex Optim
P
96
0013
Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional)
P
93
0039
CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
P
96
0030
Isoflex
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline ActFix Lead, and Vitatron Crystalline Active Fixation Lead
P
83
0061
CapSure Sense Lead and Vitatron Crystalline Lead
P
03
0036
SelectSecure Lead
P
96
0004
FINELINE II Steroid-Eluting Pacing Leads
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, and Vitatron Crystalline Active Fixation Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, and Vitatron Crystalline Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead
P
03
0036
Anchoring Sleeve Kit and SelectSecure Lead
P
03
0036
Anchoring Sleeve Kit, SelectSecure Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
P
83
0061
CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
P
93
0039
CapSureFix Novus Lead
P
83
0061
CapSure Sense Lead
P
96
0030
Isoflex
P
96
0013
Tendril SDX, OptiSense, Tendril STS, Tendril ST
P
96
0013
OptiSense Steroid Eluting Cardiac Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
93
0039
CapSureFix Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead
P
03
0036
SelectSecure Lead
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
P
03
0036
SelectSecure Lead
P
83
0061
STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING
P
03
0036
MEDTRONIC SELECTSECURE LEAD MODEL 3830
P
93
0039
MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568
P
83
0061
CapSure Sense Lead
P
96
0013
Tendril SDX, OptiSense, Tendril STS, and Tendril ST
P
96
0030
Isoflex
P
95
0024
CapSure Epicardial Pacing Lead
P
03
0036
SelectSecure Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
P
85
0089
Vitatron Impulse II Lead
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead
P
93
0039
CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
P
03
0036
Medtronic SelectSecure MRI SureScan Lead
P
03
0036
SelectSecure Lead
P
96
0013
Tendril ST and Tendril STS Low Voltage Leads
P
93
0039
CapSureFix Novus Lead; Vitatron Crystalline Active Fixation Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
83
0061
CapSure Sense Lead; Vitatron Crystalline Lead
P
03
0036
SelectSure Lead
P
93
0039
CapSureFix Novus; Vitatron Crystalline Active Fixation Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSUre SP Novus Lead and Vitatron Impulse II Lead
P
03
0036
SelectSecure Lead
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
P
83
0061
CapSure Sense Lead
P
93
0039
CapSureFix Novus Lead
P
96
0013
Tendril ST/STS Steroid Eluting Cardiac Leads
P
96
0013
TENDRIL, OPTISENSE
P
96
0030
ISOFLEX
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead
P
83
0061
CapSure Sense Leand and CapSure SP Novus Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
03
0036
SelectSecure MRI SureScan Lead
P
93
0039
CapSureFix Novus Lead
P
96
0004
FineLine II Sterox Leads, Fineline II Sterox EZ Leads, and Suture Sleeve Accessories for FineLine II Leads
P
93
0039
CapSureFix, Novus Lead
P
03
0036
Anchoring Sleeve Kit, SelectSecure Lead
P
95
0024
Capsure Epicardial Pacing Lead
P
83
0061
CapSure Sense, SP Novus; Vitaron Crystalline Lead
P
85
0089
Capsure SP, Z, Novus Lead; Vitatron Impulse II Lead.
P
95
0024
CapSure Epicardial Pacing Lead
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead and VItatron Crystalline Lead
P
03
0036
SelectSecure Lead
P
85
0089
CapSure SP Novus Lead, CapSure Sp Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead
P
93
0039
CapSureFix Novus Lead
P
83
0061
CapSure Sense Lead
P
83
0061
CapSure Sense Leads
P
93
0039
CapSureFix Novus Leads
P
83
0061
CapSure Sense MRI SureScan Lead
P
93
0039
CapSureFix Novus MRI SureScan Lead
P
03
0036
SelectSecure Lead
P
03
0036
SelectSecure MRI SureScan Lead
P
93
0039
CapSureFix Novus MRI SureScan Lead
P
83
0061
CapSure Sense MRI SureScan Lead
P
96
0006
Accessory Kit Suture Sleeve Stabilizer and Accessory Terminal Pin Fixation Tool
P
96
0004
Accessory Stylet TAPER .014 45CM, .014 52CM, .014 58CM, .016 45CM, .016 52CM, and .016 58CM, Accessory Stylet TAPER .013
P
83
0061
Adhesive, CapSure Sense Lead, CapSure SP Novvus Lead Stylet Kit and Vitatron Crystalline Lead
P
03
0036
Anchoring Sleeve Kit and SelectSecure Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Stylet Kit and Vitatron Impulse II Lead
P
93
0039
CapSureFIx Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
P
96
0004
Fineline II Sterox, EZ.
P
96
0004
Fineline II Lead Family
P
96
0013
Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps)
P
96
0013
OpticSense, Tendril STS, SDX, ST Low Voltage Active
P
96
0030
IsoFlex Low Voltage Passive
P
95
0024
CapSure Epicardial Pacing Lead
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead
P
96
0013
Tendril STS 2088TC Lead
P
96
0013
Tendril SDX Lead, Tendril ST Lead, OptiSense and Tendril STS Lead
P
96
0030
IsoFlex Optim
P
96
0013
Tendril SDX, OptiSense, Tendril STS and Tendril ST Low Voltage Active Fixation Leads
P
96
0030
Isoflex Low Voltage Passive Fixation Leads
P
03
0036
SelectSecure Lead
P
03
0036
Anchoring Sleeve Kit
P
95
0024
CapSure Epicardial Pacing Lead
P
83
0061
CapSure Sense Lead, SP Novus Lead; Vitron Crystalline Lead
P
93
0039
CapSureFix Lead, Novus Lead; Vitatron Crystalline Active Fixation Lead
P
85
0089
CapSure SP, Z Novus Lead; Vitatron Impulse II Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
P
03
0036
Anchoring Sleev Kit and SelectSecure LEad
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead and Vitatron Impulse II Lead
P
83
0061
CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead
P
96
0013
Tendrill SDX, OptiSense, Tendrill STS, Tendril ST.
P
96
0030
Isoflex
P
96
0013
Tendril and OptiSense Low Voltage Leads
P
96
0030
Isoflex Low Voltage Leads
P
96
0013
Tendril SDX Lead, Tendril ST Lead, OptiSense, Tendril STS Lead
P
96
0030
IsoFlex Optim
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, and Vitatron Crystalline Active Fixation Lead
P
85
0089
CapSure SP Novus Lead, CapSure Z Novus Lead, and Vitatron Impulse II Lead
P
03
0036
SelectSecure Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
96
0004
FINELINE II Sterox Lead, FINELINE II Sterox EZ Lead abnd Suture Sleeve Accessory (for FINELINE II Leads)
P
96
0004
Fineline II
P
96
0006
Flextend
P
96
0013
Tendril SDX, OptiSense, Tendril STS and Tendril ST
P
96
0030
IsoFlex
P
83
0061
CapSure Sense Lead; CapSure SP Novus Lead; Vitatron Crystalline Lead
P
93
0039
CapSureFix Lead; CapSureFix Novus Lead; Vitatron Crystalline Active Fixation Lead
P
85
0089
CapSure SP Novus Lead; CapSure SP Z Lead; CapSure SP Z Novus; CapSure SP Z Lead; CapSure Z Novus Lead; Vitatron Impulse
P
85
0089
Vitatron Excellence SS+ Lead
P
03
0036
SelectSecure Lead
P
93
0039
Vitatron Crystalline Active Fixation Lead and Vitatron Pirouet Lead
P
83
0061
Vitatron Crystalline Lead and Vitatron Excellence + Lead
P
93
0039
CapSureFix Novus MRi SureScan Lead and CapSureFix Novus MRI SureScan Lead
P
03
0036
SelectSecure MRI SureScan Lead
P
83
0061
CapSure Sense MRI SureScan Lead and CapSure Sense MRI SureScan Lead
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
P
03
0036
Anchoring Sleeve Kit, SelectSecure Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
83
0061
Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
P
83
0061
CapSure Sense Lead
P
93
0039
CapSureFix Novus Lead
P
96
0004
Fineline ll Lead Family
P
96
0006
Sweet Tip(R) RX Steroid Eluting Lead
P
96
0004
Thinline Endocardial Pacing Leads
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, and VItatron Crystalline Lead
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
P
93
0039
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
P
93
0039
CapSure Fix Novus Lead; Vitatron Crystalline Active Fixation Lead
P
96
0030
IsoFlex Optim Leads (lV Passive)
P
96
0013
Tendril SDX/ST/STS and Optisense Leads (LV Active)
P
96
0013
Tendril SDX, OptiSense, Tendril STS, Tendril ST
P
96
0030
IsoFlex
P
96
0030
IsoFlex
P
96
0013
OptiSense; Tendril STS, Tendril SDX, Tendril ST
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead, and Vitatron Pirouet Lead
P
85
0089
CapSure SP and Z Novus Lead, Vitatron Excellence SS+ Lead and Vitatron Impulse II Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
03
0036
Anchoring Sleeve Kit and SelectSecure Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, and Vitatron Excellence + Lead
P
03
0036
SelectSecure MRI SureScan Lead
P
83
0061
CapSure Sense MRI SureScan Lead
P
93
0039
CapSureFix Novus MRI SureScan Lead
P
96
0030
IsoFlex Optim
P
96
0013
Tendril SDX Lead, Tendril ST Lead, OptiSense, Tentril STS Lead
P
96
0013
Tendril and Optisense f Low Voltage Leads
P
96
0030
Isoflex Low Voltage Lead
P
96
0004
FINELINE II Lead Family
P
03
0036
SelectSecure Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
P
85
0089
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
93
0039
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active, Fixation Lead
P
96
0013
Tendril ST; Tendril STS; Optisense
P
85
0089
CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
P
93
0039
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
93
0039
CapSure Fix Novus Lead (4076, 5076)
P
83
0061
CapSure Sense Lead (4074, 4574)
P
96
0004
FINELINE™ II Sterox Leads, Suture Sleeve Accessory for FINELINE II Leads, (Pacing Leads and Accessories)
P
83
0061
CapSure Sense Lead/CapSure SP Novus Lead/CapSureSense Lead/Vitatron Crystalline Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
03
0036
SelectSecure Lead
P
93
0039
CapSureFix Lead/CapSureFix Novus Lead/Vitatron Crystalline Active Fixation Lead
P
85
0089
CapSure SP Novus Lead/CapSure SP Z Lead/CapSure Z Novus Lead/Vitatron Impulse II Lead
P
03
0036
SelectSecure MRI SureScan Lead
P
93
0039
CapSureFix Novus MRI SureScan Lead
P
83
0061
CapSure Sense MRI SureScan Lead
P
03
0036
SelectSecure MRI SureScan Lead
P
83
0061
CapSureFix Novus MRI SureScan Lead (4074 and 4574)
P
93
0039
CapSureFix Novus MRI SureScan Lead
P
93
0039
CapSureFix Lead/ CapSureFix Novus Lead/ Vitatron Crystalline Active Fixation Lead
P
83
0061
CapSure Sense Lead/ CapSure SP Novus Lead/Vitatron Crystalline Lead
P
85
0089
CapSure SP Novus Lead/ CapSure SP Z Lead/ CapSure Z Novus Lead/ Vitatron Impulse II Lead
P
93
0039
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation/Pirouet Lead
P
95
0024
CapSure Epicardial Pacing Lead
P
83
0061
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
P
85
0089
CapSure SP/Z Novus Lead, Vitatron Excellence SS+/Impulse II Lead
P
93
0039
CapSureFix Novus Lead 4076, 5076 - Vitatron Crystalline Active Fixation Lead ICF09, ICF09B, ICFQ09B
P
95
0024
CapSure Epicardial Pacing Lead
P
93
0039
CapSureFix/CapSureFix Novus/Vitatron Crystalline Active Fixation Lead
P
83
0061
CapSure Sense/CapSure SP/CapSure SP Novus/CapSureSense/Vitatron Crystalline Lead
P
85
0089
CapSure SP Novus/CapSure SP Z/CapSure Z Novus/Vitatron Impulse II Lead
P
96
0004
Fineline II Sterox and Sterox EZ Lead
P
83
0061
CAPSURE SENSE MRI SURESCAN LEAD
P
83
0061
CAPSURE SENSE MRI SURESCAN LEAD
P
93
0039
CAPSUREFIX NOVUS MRI SURESCAN LEAD
P
03
0036
SELECTSECURE LEAD MODEL 3830
P
03
0036
SELECTSECURE MRI SURESCAN LEAD
P
93
0039
CAPSUREFIX NOVUS MRI SURESCAN LEAD
P
83
0061
CAPSURE SENSE MRI SURESCAN LEAD MODEL 4574
P
03
0036
SELECTSECURE MRI SURESCAN LEAD MODEL 3830
P
93
0039
CAPSURE FIX NOVUS MRI SURESCAN LEAD MODELS 5076 AND 4076
P
93
0039
CapSureFix Novus MRI SureScan Lead
P
83
0061
CapSure Sense MRI SureScan Leads
P
03
0036
MEDTRONIC SELECTSECURE LEAD MODEL 3830
P
96
0004
FINELINE II Sterox and Sterox EZ Lead
P
96
0004
FINELINE II STEROX & FINELINE II STEROX EZ, SUTURE SLEEVE ACCESSORY(FOR FINELINE II LEADS)
P
96
0013
Tendril SDX Lead, Tendril ST Lead, OptiSence, Tendril STS Lead
P
96
0030
IsoFlex Optim
P
96
0030
IsoFlex Optim leads (LV Passive)
P
96
0013
Tendril SDX/ST/STS and optisense leads (LV active)
P
96
0013
Tendril SDX/ST/STS and Optisense leads (LV Active)
P
96
0030
IsoFlex Optim leads (LV Passive)
P
96
0030
ISOFLEX OPTIM LEADS (LV PASSIVE)
P
96
0013
TENDRIL SDX/ST/STS AND OPTISENSE LEADS (LV ACTIVE)
P
93
0039
CAPSUREFIX NOVUS LEAD ; VITATRON CRYSTALLLINE ACTIVE FIXATION LEAD
P
85
0089
CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS
P
83
0061
CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD
P
95
0024
MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
P
96
0030
IsoFlex Optim leads
P
96
0013
Tendril SDX, Tendril ST, Tendril STS and Optisense leads
P
96
0030
ISOFLEX OPTIM LEADS (LV PASSIVE)
P
96
0013
TENDRIL SDX, TENDRIL ST, TENDRIL STS AND OPTISENSE LEADS (LV ACTIVE)
P
03
0036
SELECTSECURE LEAD
P
95
0024
CapSure Epicardial Pacing Lead
P
85
0089
CAPSURE SP NOVUS LEAD / Z LEAD ; CAPSURE Z NOVUS LEAD ; VITATRON IMPLUSE II LEAD
P
93
0039
CAPSUREFIX LEAD; CAPSUREFIX NOVUS LEAD; VITATRON CRYSTALLINE ACTIVE FIXATION LEAD
P
83
0061
CAPSURE SENSE LEAD /SP LEAD / CAPSURE SP NOVUS LEAD/ VITATRON CRYSTALLINE LEAD/ VITATRON EXCELLENCE PS + LEAD
P
83
0061
ADHESIVE, CAPSURE SENSE LEAD, CAPSURE SP LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE AND EXCELLENCE PS+ LEAD
P
95
0024
CapSure Epicardial Pacing Lead
P
85
0089
CAPSURE SP NOVUS, CAPSURE SP Z, CAPSURE Z NOVUS, VITATRON IMPULSE II LEAD
P
93
0039
MEDTRONIC(R) CAPSUREFIX LEAD
P
03
0036
MEDTRONIC SELECTSECURE LEAD/ANCHORING SLEEVE KIT
P
96
0030
IsoFlex Optim Leads
P
96
0013
TENDRIL SDX, TENDRIL ST, TENDRIL STS AND OPTISENSE LEADS
P
93
0039
CAPSUREFIX/CAPSUREFIX NOVUS/VITATRON CRYSTALLINE ACTIVE FIXATION LEADS
P
83
0061
ADHESIVE/CAPSURE SENSE/CAPSURE SP NOVUS/VITATRON CRYSTALLINE/VITATRON EXCELLENCE PS+ LEADS
P
85
0089
CAPSURE SP NOVUS/CAPSURE SP Z/CAPSURE Z NOVUS/VITATRON IMPULSE II LEADS
P
95
0024
CAPSURE EPICARDIAL PACING LEAD
P
03
0036
ANCHORING SLEEVE KIT/SELECTSECURE LEAD
P
93
0039
MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568
P
83
0061
CAPSURE SENSE MRI SURESCAN LEAD MODEL 4574
P
93
0039
CapSureFix Novus Lead 4076, 5076
P
93
0039
CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076
P
83
0061
CAPSURE SENSE MRI SURESCAN LEAD MODELS 4074 AND 4574.
P
93
0039
CapSureFix Novus Lead; Vitatron Crystalline; Active Fixation Lead
P
83
0061
CapSure Sense, SP Novus Lead: Vitatron Crystalline, Excellence PS+ Lead;
P
83
0061
CAPSURE SENSE LEAD; CAPSURE SP NOVUS LEAD; VITATRON CYRSTALLINE LEAD; VITATRON EXCELLENCE PS+ LEAD
P
85
0089
CAPSURE SP NOVUS/CAPSURE SP Z/CAPSURE Z NOVUS LEADS, VITATRON IMPULSE II LEAD
P
93
0039
CAPSUREFIX,CAPSUREFIX NOVUS, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD
P
96
0013
TENDRIL ST, STS AND OPTISENSE LV LEADS
P
83
0061
CapSure Sense Lead Models 4074, 4574
P
93
0039
CapSureFix Novus Lead Model 4076
P
83
0061
CapSure Sense Lead; Vitatron Crystalline Lead, ICM09
P
93
0039
CapSure Fix Novus Lead; Vitatron Crystalline Active; Fixation Lead, ICF09, ICQ09B
P
83
0061
Capsure Sense MRI SureScan Lead Model 4074, Capsure Sense MRI SureScan Lead Model 4574
P
93
0039
CapSureFix MRI 4076,CapSureFix Novus MRI 5076, CapSureFix MRI SureScan 5086MRI LEAD MODELS
P
93
0039
CapSureFix Novus Lead
P
93
0039
MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568
P
93
0039
CAPSUREFIX NOVUS LEAD
P
03
0036
SELECTSECURE LEAD
P
96
0004
FINELINE II
P
95
0037
Solia S 45, 53, 60 Siello S 45, 53, 60 Drug-Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Elec
P
96
0013
TENDRIL SDX, TENDRIL ST, TENDRIL STS, OPTISENSE
P
96
0030
ISOFLEX OPTIM
P
93
0039
CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD
P
03
0036
SELECTSECURE LEAD
P
95
0024
CAPSURE EPICARDIAL PACING LEAD
P
85
0089
CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD
P
83
0061
ADHESIVE, CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD
P
95
0001
SELUTE Pacing Lead Family
P
96
0006
SWEET TIP RX, SWEET PICOTIP Rx, and FLEXTEND Pacing Lead Families
P
96
0004
THINLINE/FINELINE Family of ENDOCARDIAL PACING LEADS
P
96
0030
IsoFlex Optim LV leads
P
96
0013
Tendril SDX, ST, STS and OptiSense LV leads
P
96
0004
FINELINE II STEROX AND STEROX EZ LEADS
P
96
0030
IsoFlex 1944, 1948
P
96
0013
Tendril ST 1888/1882 TC; Tendril STS 2088 TC; Optisense 1999
P
96
0013
TENDRIL SDX LEAD, TENDRIL ST LEAD, OPTISENSE, TENDRIL STS LEAD
P
96
0030
ISOFLEX OPTIM
P
93
0039
CapSureFix Novus Lead 5076; Vitatron Crystalline
P
83
0061
CapSure Sense Lead 4074, 4574; CapSure SP Novus Lead 4092, 4592
P
85
0089
CapSure SP Novus Lead 5092, 5592, 5594; CapSure Z Novus Lead 5054, 5554
P
96
0030
IsoFlex Models 1642T, 1646T, 1944, 1948
P
96
0030
ISOFLEX OPTIM LV LEADS
P
96
0004
FINELINE II STEROX IMPLANTABLE CARDIAC ENDOCARDIAL PACING LEADS
P
96
0004
FINELINE II STEROX AND STEROX EZ ENDOCARDIAL PACING LEAD
P
96
0004
FINELINE II STEROX ENDOCARDIAL PACING LOEADS & FINELINE II STEROX EZ ENDOCARDIAL PACING LEADS
P
96
0013
TENDRIL SDX, TENDRIL ST, OPTISENSE, TENDRIL STS FAMILY OF LV LEADS
P
96
0030
ISOFLEX OPTIM FAMILY OF PACING LEADS
P
96
0004
FINELINE II STEROID-ELUTING PACING LEADS, PASSIVE AND ACTIVE FIXATIONS MODELS
P
96
0013
TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS
P
96
0004
FINELINE 2 PACING LEADS
P
96
0004
FINELINE II STEROX ENDOCARDIAL PACING LEAD
P
96
0004
FINELINE II PACE/SENSE LEAD
P
96
0004
FINELINE II STEROID-ELUTING PACING LEADS
P
01
0012
EASY TRAK 2 FAMILY
P
93
0039
MEDTRONIC CAPSUREFIX NOVUS MRI SURESCAN MODEL 5076 LEAD
P
96
0004
THIN/LINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS
P
96
0004
THINLINE AND FINELINE TRANSVENOUS ENDOCARDIAL PACING LEADS
P
96
0004
FINELINE II STEROX
P
96
0030
ISOFLEX FAMILY OF LEADS (1944,1948)
P
96
0013
TENDRIL AND OPTISENSE FAMILY OF LEADS
P
96
0004
THINLINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS
P
96
0004
FINELINE II STEROX LEAD
P
96
0004
FINLINE LEAD FAMILY
P
96
0013
TENDRILL STS MODEL 2088TC LEAD
P
96
0004
THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS
P
95
0024
CAPSURE EPI PACING LEADS
P
95
0024
CAPSURE EPI PACING LEADS
P
96
0004
THINLINE/FINELINE FAMILIES OF PACING LEADS
P
03
0036
MEDTRONIC SELECTSECURE LEAD MODEL 3830
P
96
0013
TENDRIL SDX, TENDRIL ST, TENDRIL STS, OPTISENSE
P
96
0004
THINLINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS AND ACCESSORIES
P
96
0004
THINLINE/FINELINE LEADS FAMILIES
P
96
0004
THINLINE II AND FINELINE II STEROX LEADS AND FINELINE II EZ STEROX LEADS
P
96
0013
TENDRIL FAMILY OF LEADS
P
96
0004
FINELINE 11 AND THINLINE II
P
96
0004
THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS
P
96
0013
TENDRIL (TENDRIL, TENDRIL ST, TENDRIL STS) AND OPTISENSE FAMILY OF LEADS
P
96
0004
THINLINE / FINELINE FAMILY OF ENDOCARDIAL PACING LEADS
P
96
0030
PASSIVE PLUS AND IOSFLEX LEAD FAMILIES
P
96
0013
TENDRIL AND OPTISENSE LEAD FAMILIES
P
96
0013
CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE
P
96
0004
THINLINE II STEROX, FINELINE II STEROX & FINELINE II STEROX EZ LEADS
P
96
0013
OPTISENSE LEAD MODEL 1999 TUBING
P
96
0013
TENDRIL STS 1988TC AND 2088TC
P
96
0013
TENDRIL FAMILY OF LEADS
P
96
0013
TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS
P
96
0013
TENDRIL STS
P
09
0013
REVO MRI
P
96
0013
TENDRIL/TENDRIL ST & STS/OPTISENSE
P
96
0004
THINLINE/FINELINE FAMILIES
P
96
0013
1782 TENDRIL LEADS
P
03
0036
MEDTRONIC SELECTSECURE LEAD MODEL 3830
P
96
0004
THINLINE II, STEROX, FINELINE II STEROX AND FINELINE II STEROX EZ
P
96
0013
TENDRIL LEADS
P
96
0013
OPTISENSE MODEL 1999 LEAD
P
96
0004
THINLINE/FINELINE
P
96
0013
TENDRIL STS MODELS 2088TC & 1988TC LEADS
P
96
0013
OPTISENSE 1999 LEAD
P
96
0013
TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS
P
96
0013
TENDRIL STS LEAD MODEL 1988TC
P
96
0013
TENDRIL/TENDRIL ST/TENDRIL STS/OPTISENSE LEADS
P
96
0013
TENDRIL LEADS
P
96
0004
THINLINE/FINELINE
P
96
0004
THINLINE II STEROX/THINLINE II STEROX/EZ/FINELINE II STEROX/EZ/TAPERED STYLET
P
96
0013
TENDRIL LEADS
P
96
0013
OPTISENSE RIGHT ATRIAL LEAD
P
96
0013
TENDRIL/TENDRIL ST & OPTISENSE FAMILIES OF LEADS
P
96
0013
TENDRIL 1888 LEADS
P
96
0013
TENDRIL 1888 LEAD
P
96
0013
TENDRIL ST LEAD MODEL 1882 LEADS
P
96
0013
TENDRIL/TENDRIL ST/OPTISENSE LEADS
P
96
0004
FINELINE II/THINLINE II BRADY LEADS
P
96
0013
TENDRIL STS LEAD MODEL 2088TC
P
96
0013
ST JUDE MEDICAL TENDRIL ST MODEL 1888 LEAD
P
96
0004
FINELINE II STEROX EZ LEADS
P
03
0036
MEDTRONIC SELECTSECURE LEAD MODEL 3830
P
02
0030
STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD
P
96
0006
SWEET TIP(R) RX STEROID ELUTING LEAD
P
96
0030
PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS
P
96
0013
TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS
P
96
0004
THINLINE ENDOCARDIAL PACING LEADS
P
95
0024
MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
P
95
0001
SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
P
93
0039
MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568
P
85
0089
CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS
P
83
0061
STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING
NVY
Permanent Defibrillator Electrodes
NVZ
Pulse Generator, Permanent, Implantable
NWX
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
OAD
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
OAE
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
OBC
Occluder, Internal Vessel, Temporary
OBD
Barrier, Adhesion, Cardiovascular
OCM
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
ODT
Tissue Adhesive, Aortic Aneurysmorrhaphy
OHA
Heart Valve, More Than Minimally Manipulated Allograft
OJE
Right Ventricular Bypass (Assist) Device
OJX
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
ONU
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
OSR
Pacemaker/Icd/Crt Non-Implanted Components
OZD
Temporary Non-Roller Type Left Heart Support Blood Pump
OZG
Transcatheter Septal Occluder (Atrial)
OZH
Transcatheter Septal Occluder (Ventricular)
PAP
Aortic Heart Valve, More Than Minimally Manipulated Allograft
PCW
Implantable Pulse Generator, Programmer And Battery Charger
PCX
Artificial Chordae Tendinae Delivery System
PFV
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
PIZ
Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve
PJQ
Agent, Occluding, Vascular, Permanent
PKK
Stent Delivery System
PNF
Aortic Stent
PNY
Absorbable Coronary Drug-Eluting Stent
PRC
Drug-Coated Peripheral Transluminal Angioplasty Catheter
PRL
Iliac Covered Stent, Arterial
QAN
Stent, Iliac Vein
QBI
Acute Coronary Syndrome Event Detector
QCT
Scaffold, Dissection Repair
QFV
Implantable Pulse Generator
QLJ
Patient Monitor With Independent Remote Display And Operation
QLL
Left Ventricular Ejection Fraction Screening Tool
QLM
Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool
QLN
Extracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19
QMG
Shockwave Intravascular Lithotripsy System
QNY
Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring
QNZ
Powered Communication System For Emergency Use
QOA
Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening
QOC
Temporary Non-Roller Type Left Or Right Heart Support Blood Pump
QIK
Organ Care System (Ocs) Heart System
QSK
Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
QWA
Cardiovascular Delivery Catheter System Positioning And Stabilization Device
QWM
Stent Graft, Bypass, Superficial Femoral Artery
QXO
Cardiovascular Machine Learning-Based Notification Software
QWC
Pulmonary Stent
QVQ
Extravascular Support For An Arteriovenous Fistula For Vascular Access
QXV
Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
QWN
Stent Graft, Infrapopliteal, Venous Arterialization
QXU
Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
QXX
Coronary Artery Disease Machine Learning-Based Notification Software
QYE
Reduced Ejection Fraction Machine Learning-Based Notification Software
QVG
Embolization Agent, Vascular
QYI
Ablation Catheter, Renal Denervation
QYU
Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
QZI
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
QZK
Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions
QZU
Temporary Embolization Assist Device, Peripheral
NPW
Percutaneously Delivered Prostheses And Tricuspid Valves
OOB
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
NPS
Tricuspid Valve Repair Device, Percutaneously Delivered
SAT
Pulmonary Hypertension Machine Learning-Based Notification Software
SBK
Artificial Chordae Tendineae Surgical Replacement System
SBQ
Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
QXY
Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification
SCZ
Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
NXW
Scaffold, Infrapopliteal, Absorbable
SEG
Leadless Cardiac Resynchronization Therapy (Crt)
SEU
Peripheral Temporary And Retrievable Stent System
SFR
Hypertension Machine Learning-Based Notification Software
QKJ
Stent, Central Venous
SEQ
Covered Stent Vascular Connector, Hemodialysis Access Circuit
SGO
Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
Submissions with No Product Code
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
Subpart E—Cardiovascular Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Therapeutic Devices
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
CV
/
CV-misc
/
NVN
/
P090013
View Source
REVO MRI
Page Type
PMA Approval
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Medtronic, Inc
Trade Name
REVO MRI SURESCAN IPG AND PACING SYSTEM
Generic Name
Implantable pulse generator, pacemaker (non-CRT)
Decision Date
2/8/2011
Days to Decision
609 days
Decision Code
APPR
FDA Decision
Approval