FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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
P
17
0006
AVALUS(TM) BIOPROSTHESIS
APPR
PMA Approval
P
15
0048
EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)
APPR
PMA Approval
P
15
0036
EDWARDS INTUITY ELITE VALVE SYSTEM
APPR
PMA Approval
P
15
0011
PERCEVAL SUTURELESS HEART VALVE
APPR
PMA Approval
P
13
0011
FREEDOM SOLO STENTLESS HEART VALVE
APPR
PMA Approval
P
10
0029
ST JUDE MEDICAL TRIFECTA VALVE
APPR
PMA Approval
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS
APWD
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
APPR
PMA Approval
P
04
0021
SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE
APPR
PMA Approval
P
97
0031
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
APPR
PMA Approval
P
15
0048
Edwards INSPIRIS RESILIA Aortic Valve
3
PMA Approval
P
15
0048
KONECT RESILIA Aortic Valved Conduit (AVC)
3
PMA Approval
P
04
0021
Epic and Epic Supra Tissue Heart Valves
3
PMA Approval
P
15
0048
RESILIA Solutions System
3
PMA Approval
P
15
0048
KONECT RESILIA Aortic Valved Conduit (AVC)
3
PMA Approval
P
15
0011
Perceval Sutureless Heart Valve, Perceval PLUS
3
PMA Approval
P
97
0031
Freestyle Bioprosthesis
3
PMA Approval
P
79
0007
Hancock Modified Orifice Valved Conduit
3
PMA Approval
P
79
0007
Hancock Modified Orifice Valved Conduit
3
PMA Approval
P
97
0031
Freestyle Bioprosthesis
3
PMA Approval
P
15
0036
EDWARDS INTUITY Elite Valve
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve
3
PMA Approval
P
04
0021
Biocor, Biocor Supra, Epic and Epic Supra Tissue Heart Valves
3
PMA Approval
P
17
0006
Avalus Bioprosthesis
3
PMA Approval
P
15
0036
EDWARDS INTUITY Elite Valve
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valv
3
PMA Approval
P
17
0006
Avalus Bioprosthesis
3
PMA Approval
P
15
0011
Perceval Sutureless Heart Valve
3
PMA Approval
P
04
0021
Biocor, Biocor Supra, Epic, Epic Supra
3
PMA Approval
P
10
0029
Trifecta and Trifecta Valve with Glide Technology
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valv
3
PMA Approval
P
15
0036
EDWARDS INTUITY Elite Delivery System
3
PMA Approval
P
17
0006
Avalus Bioprosthesis
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis
3
PMA Approval
P
15
0048
KONECT RESILIA Aortic Valved Conduit AVC
3
PMA Approval
P
15
0011
Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve
3
PMA Approval
P
04
0021
Biocor, Biocor Supra, Epic, and Epic Supra Valves
3
PMA Approval
P
15
0036
Edwards INTUITY Elite Tube Extrusion
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve
3
PMA Approval
P
15
0036
EDWARDS INTUITY Elite Valve
3
PMA Approval
P
15
0011
Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve
3
PMA Approval
P
13
0011
Solo Smart Heart Valve
3
PMA Approval
P
15
0036
EDWARDS INTUITY Elite Valve System
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Edwards pericardial Mitral Bioprosthesis and Edwards INSPIRIS RESILIA Aortic V
3
PMA Approval
P
15
0036
EDWARDS INTUITY Elite Aortic Valve
3
PMA Approval
P
15
0011
Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve
3
PMA Approval
P
13
0011
Solo Smart Heart Valve
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis
3
PMA Approval
P
15
0036
EDWARDS INTUITY Elite Valve
3
PMA Approval
P
15
0011
Perceval Sutureless Heart Valve
3
PMA Approval
P
79
0007
Hancock Valved Conduit Modified Orifice
3
PMA Approval
P
17
0006
Avalus
3
PMA Approval
P
97
0031
Freestyle Bioprosthesis
3
PMA Approval
P
10
0029
Trifecta and Trifecta GT Heart Valves
3
PMA Approval
P
04
0021
Biocor, Biocor Supra, Epic and Epic Supra Heart Valves
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprostheses and Edwards Inspiris Resilia Aortic Valve
3
PMA Approval
P
15
0036
Edwards Intuity Valves and Delivery Systems
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Pericardial Mitral Bioprosthesis, and Inspiris Resilia Aortic Valve
3
PMA Approval
P
15
0036
Edwards Intuity Elite Valve System
3
PMA Approval
P
06
0038
Mitroflow Aortic Pericardial Heart Valve
3
PMA Approval
P
15
0036
Edwards Intuity Elite Valve System
3
PMA Approval
P
15
0048
Edwards Inspiris Resilia Aortic Valve
3
PMA Approval
P
15
0036
Edwards Intuity Elite Delivery System
3
PMA Approval
P
15
0036
Edwards Intuity Elite Valve System
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Valve, and Edwards Pericardial Mitral Bioprosthesis
3
PMA Approval
P
15
0036
Edwards Intuity Elite Valve
3
PMA Approval
P
15
0048
Edwards INSPIRIS RESILIA Aortic Valve
3
PMA Approval
P
15
0036
Edwards Intuity Elite Valve System
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic/Mitral Bioprosthesis and Edwards Inspiris Resilia Aortic Valve
3
PMA Approval
P
17
0006
Avalus Bioprosthesis
3
PMA Approval
P
17
0006
Avalus Bioprosthesis
3
PMA Approval
P
97
0031
Freestyle Bioprosthesis
3
PMA Approval
P
79
0007
Hancock Valved Conduit
3
PMA Approval
P
17
0006
Avalus Bioprosthesis
3
PMA Approval
P
15
0048
Edwards Pericradial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve
3
PMA Approval
P
15
0036
Edwards Intuity Elite Valve System
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Pericardial Mitral Bioprosthesis, and Inspiris Resilia Aortic Valve
3
PMA Approval
P
17
0006
Avalus Bioprosthesis
3
PMA Approval
P
10
0029
Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT)
3
PMA Approval
P
04
0021
Biocor, Biocor Supra, Epic, and Epic Supra Valves
3
PMA Approval
P
17
0006
Avalus Bioprosthesis
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprothesis
3
PMA Approval
P
04
0021
Biocor and Epic Valves
3
PMA Approval
P
10
0029
Trifecta and Trifecta GT surgical Heart Valve
3
PMA Approval
P
15
0011
Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve
3
PMA Approval
P
13
0011
Solo Smart Heart Valve
3
PMA Approval
P
10
0029
Trifecta/Trifecta GT Valves
3
PMA Approval
P
04
0021
Biocor/Epic Valves
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis
3
PMA Approval
P
15
0036
EDWARDS INTUITY Elite Valve System
3
PMA Approval
P
97
0031
Freestyle Aortic Root Bioprosthesis
3
PMA Approval
P
79
0007
Hancock Valved Conduit LP
3
PMA Approval
P
17
0006
Avalus Bioprosthesis
3
PMA Approval
P
04
0021
Biocor Valve, Supra Valve; Epic Valve, Supra
3
PMA Approval
P
17
0006
Avalus Bioprosthesis
3
PMA Approval
P
15
0011
Perceval Heart Valve
3
PMA Approval
P
04
0021
Biocor, Biocor Supra, Epic, Epic Supra Valves
3
PMA Approval
P
15
0011
Perceval Heart Valve
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve
3
PMA Approval
P
17
0006
Medtronic CoreValve Evolut PRO TAV, and Avalus Bioprosthesis
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve
3
PMA Approval
P
15
0036
EDWARDS INTUITY Elite Valve System
3
PMA Approval
P
15
0036
EDWARDS INTUITY ELITE Valve/Delivery System
3
PMA Approval
P
15
0036
EDWARDS INTUITY Elite Valve System
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve
3
PMA Approval
P
15
0036
EDWARDS INTUITY Elite Valve System
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve
3
PMA Approval
P
10
0029
Trifecta Valve with Glide Technology (Trifecta GT) Trifecta Valve.
3
PMA Approval
P
15
0048
Edwards Pericardial Mitral Bioprosthesis
3
PMA Approval
P
79
0007
Hancock Valved Conduit Modified Orifice
3
PMA Approval
P
10
0029
Trifecta Valve with Glide Technology (Trifecta GT)
3
PMA Approval
P
10
0029
Trifecta Valve / Trifecta Valve with Glide Technology (Trifecta GT )
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis / Edwards Inspiris Resilia Aortic Valve
3
PMA Approval
P
15
0048
Edwards Pericardial Mitral Bioprosthesis, Model 11000M
3
PMA Approval
P
17
0006
Avalus Bioprosthesis
3
PMA Approval
P
15
0036
EDWARDS INTUITY Elite Valve System
3
PMA Approval
P
15
0036
EDWARDS INTUITY ELITE Valve System
3
PMA Approval
P
15
0048
Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis
3
PMA Approval
P
06
0038
Mitroflow Aortic Pericardial Heart Valve
3
PMA Approval
P
79
0007
Hancock Modified Orifice Valved Conduit
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Model 11500A
3
PMA Approval
P
15
0036
EDWARDS INTUITY Valve System
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis/ Edwards INSPIRIS RESILIA Aortic Valve
3
PMA Approval
P
04
0021
St.Jude Medical Biocor, Epic and Epic Supra Valves
3
PMA Approval
P
10
0029
Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT )
3
PMA Approval
P
15
0048
Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis
3
PMA Approval
P
15
0036
EDWARDS INTUITY ELITE Valve System
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Edwards Inspiris Resilia Aortic Valve
3
PMA Approval
P
15
0036
Edwards Intuity Elite Valve System, Aortic Valve Model 8300AB and Delivery System Model 8300DB
3
PMA Approval
P
79
0007
Hancock Modified Orifice Valved Conduit
3
PMA Approval
P
97
0031
Freestyle Aortic Root Bioprosthesis
3
PMA Approval
P
10
0029
Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT)
3
PMA Approval
P
04
0021
Biocor Valve, Epic Valve, Epic Supra Valve
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprothesis, Inspiris Resilia Aortic Valve
3
PMA Approval
P
15
0036
Edwards Intuity Elite Valve System
3
PMA Approval
P
10
0029
Trifecta Valve/Trifecta Valve with Glide Technology (Trifecta GT)
3
PMA Approval
P
15
0036
Edwards Intuity Elite Valve System
3
PMA Approval
P
06
0038
Mitroflow Aortic Pericardial Heart Valve
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Edwards Inspiris Resilia Aortic Valve
3
PMA Approval
P
15
0036
Edwards Intuity Elite Valve System
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve
3
PMA Approval
P
15
0036
Edwards Intuity Elite Valve System
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis (Resilia tissue)
3
PMA Approval
P
15
0011
Perceval Sutureless Heart Valve
3
PMA Approval
P
13
0011
Solo Smart Stentless Heart Valve
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis and Inspiris Resilia Aortic
3
PMA Approval
P
15
0048
INSPIRIS RESILIA Aortic Valve
3
PMA Approval
P
10
0029
Trifecta and Trifecta GT
3
PMA Approval
P
10
0029
Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT)
3
PMA Approval
P
15
0011
Perceval Sutureless Heart Valve
3
PMA Approval
P
15
0036
EDWARDS INTUITY ELITE Valve System
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis (RESILIA tissue)
3
PMA Approval
P
04
0021
Biocor and Epic Heart Valves
3
PMA Approval
P
10
0029
Trifecta Heart Valves
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis
3
PMA Approval
P
15
0036
EDWARDS INTUITY Elite Valve System
3
PMA Approval
P
15
0036
EDWARDS INTUITY Elite Valve System, Aortic Valve and Delivery System
3
PMA Approval
P
97
0031
Freestyle Aortic Root Bioprosthesis
3
PMA Approval
P
79
0007
Hancock Modified Orifice Valved Conduit
3
PMA Approval
P
15
0048
Inspiris Resilia Aortic Valve
3
PMA Approval
P
04
0021
Biocor Heart Valve
3
PMA Approval
P
10
0029
Trifecta Heart Valve
3
PMA Approval
P
17
0006
Avalus Bioprosthesis, Model 400
3
PMA Approval
P
97
0031
Freestyle Bioprosthesis
3
PMA Approval
P
79
0007
Hancock Modified Orifice Valved Conduit
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve
3
PMA Approval
P
15
0036
EDWARDS INTUITY ELITE Valve System
3
PMA Approval
P
15
0048
RESILIA Aortic Valve
3
PMA Approval
P
15
0036
EDWARDS INTUITY ELITE Valve System
3
PMA Approval
P
15
0048
Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis
3
PMA Approval
P
10
0029
Trifecta Valve with Glide Technology (Trifecta GT)
3
PMA Approval
P
17
0006
Avalus Bioprosthesis
3
PMA Approval
P
17
0006
Avalus
3
PMA Approval
P
97
0031
Freestyle Bioprosthesis
3
PMA Approval
P
97
0031
Freestyle Bioprosthesis
3
PMA Approval
P
17
0006
Avalus Bioprosthesis Valve
3
PMA Approval
P
79
0007
Hancock Modified Orific Valved Conduit.
3
PMA Approval
P
04
0021
Biocor and Epic Heart Valves
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis/Inspiris Resilia Aortic Valve
3
PMA Approval
P
15
0036
Edwards Intuity Elite Valve System
3
PMA Approval
P
15
0036
EDWARDS INTUITY Elite Valve System
3
PMA Approval
P
15
0036
EDWARDS INTUITY ELITE Valve System
3
PMA Approval
P
15
0048
Edwards Pericardial Aortic Bioprosthesis
3
PMA Approval
P
97
0031
Freestyle Bioprosthesis, Model 995, 995SC and 995MS
3
PMA Approval
P
79
0007
Hancock Modified Orifice (MO) Valved Conduit, Model 150
3
PMA Approval
P
17
0006
AVALUS(TM) BIOPROSTHESIS
3
PMA Approval
P
15
0036
Edwards INTUITY Elite Valve System
3
PMA Approval
P
15
0011
Perceval Sutureless Heart Valve
3
PMA Approval
P
15
0036
EDWARDS INTUITY ELITE Valve System
3
PMA Approval
P
15
0036
EDWARDS INTUITY Valve System
3
PMA Approval
P
15
0048
EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)
3
PMA Approval
P
15
0036
Intuity Elite Valve System
3
PMA Approval
P
15
0036
EDWARDS INTUITY VALVE SYSTEM
3
PMA Approval
P
15
0036
Edwards Intuity Valve System
3
PMA Approval
P
15
0036
Edwards Intuity Elite Valve & Delivery System
3
PMA Approval
P
15
0036
EDWARDS INTUITY Valve System
3
PMA Approval
P
15
0036
EDWARDS INTUITY Valve System
3
PMA Approval
P
15
0036
EDWARDS INTUITY VALVE SYSTEM
3
PMA Approval
P
15
0036
EDWARDS INTUITY Elite Valve System
3
PMA Approval
P
10
0029
Trifecta Valve with Glide
3
PMA Approval
P
97
0031
Freestyle Bioprosthesis, Models 995, 995CS and 995MS
3
PMA Approval
P
15
0011
Perceval Sutureless Heart Valve
3
PMA Approval
P
79
0007
Hancock Valved Conduit
3
PMA Approval
P
97
0031
Freestyle Bioprosthesis
3
PMA Approval
P
15
0036
EDWARDS INTUITY ELITE VALVE SYSTEM
3
PMA Approval
P
15
0011
PERCEVAL SUTURELESS HEART VALVE
3
PMA Approval
P
15
0011
PERCEVAL SUTURELESS HEART VALVE
3
PMA Approval
P
15
0036
EDWARDS INTUITY ELITE VALVE SYSTEM (AORTIC VALVE MODEL 8300AB)
3
PMA Approval
P
97
0031
MEDTRONIC FREESTYLE BIOPROSTHESIS
3
PMA Approval
P
10
0029
TRIFECTA VALVE, VALVE WITH GLIDE
3
PMA Approval
P
04
0021
SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE
3
PMA Approval
P
15
0036
EDWARDS INTUITY ELITE VALVE SYSTEM
3
PMA Approval
P
15
0011
PERCEVAL HEART VALVE
3
PMA Approval
P
10
0029
ST JUDE MEDICAL TRIFECTA VALVE
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
3
PMA Approval
P
04
0021
SJM BIOCOR AND EPIC VALVES
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
15
0011
PERCEVAL SUTURELESS HEART VALVE
3
PMA Approval
P
13
0011
SOLO SMART STENTLESS HEART VALVE
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
15
0036
EDWARDS INTUITY ELITE VALVE SYSTEM
3
PMA Approval
P
04
0021
SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE
3
PMA Approval
P
10
0029
BIOCOR VALVE, SUPRA VALVE; EPIC VALVE, SUPRA VALVE; TRIFECTA VALVE, TRIFECTA VALVE WITH GLIDE TECHONOLOGY (TRIFECTA GT)
3
PMA Approval
P
04
0021
BIOCOR VALVE, SUPRA VALVE; EPIC VALVE, SUPRA VALVE; TRIFECTA VALVE, TRIFECTA VALVE WITH GLIDE TECHONOLOGY (TRIFECTA GT)
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
3
PMA Approval
P
15
0011
PERCEVAL SUTURELESS HEART VALVE
3
PMA Approval
P
79
0007
THE HANCOCK VALVED CONDUIT MODIFIED ORIFICE (MODEL 105)
3
PMA Approval
P
13
0011
FREEDOM SOLO STENTLESS HEART VALVE
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
15
0011
PERCEVAL SUTURELESS HEART VALVE
3
PMA Approval
P
10
0029
TRIFECTA VALVE WITH GLIDE TECHNOLOGY
3
PMA Approval
P
13
0011
THE SOLO SMART STENTLESS HEART VALVE
3
PMA Approval
P
15
0011
THE PERCEVAL SUTURELESS HEART VALVE
3
PMA Approval
P
15
0011
PERCEVAL SUTURELESS HEART VALVE
3
PMA Approval
P
13
0011
SOLO SMART STENTLESS HEART VALVE (SOLO SMART)
3
PMA Approval
P
06
0038
Crown PRT Aortic Pericardial Heart Valve with PR Treatment
3
PMA Approval
P
15
0011
PERCEVAL SUTURELESS HEART VALVE
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALUED CONDUIT
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
06
0025
3F AORTIC BIOPROSTHESIS
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
13
0011
SOLO SMART STENTLESS HEART VALVE
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
99
0064
MOSAIC PORCINE BIOPROSTHETIC HEART VALVE
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
04
0021
BIOCOR, EPIC AND EPIC SUPRA VALVE
3
PMA Approval
P
06
0038
MTROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART CALVE WITH PHOSPHOLIPID REDUCTION TREATMENT
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS(MODELS 995, 995CS, 995MS)
3
PMA Approval
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS- (MODELS 305. 310)
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT-(MODEL 150)
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
99
0064
MOSIAC PORCINE BIOPOROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
06
0025
MEDTRONIC 3F AORTIC BIOPROSTHESIS MODEL 1000
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
3
PMA Approval
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL
3
PMA Approval
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
3
PMA Approval
P
13
0011
FREEDOM SOLO STENTLESS HEART VALVE
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
3
PMA Approval
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL
3
PMA Approval
P
04
0021
BIOCOR AND EPIC VALVE
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
3
PMA Approval
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE (MO) VALUED CONDUIT
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
04
0021
BIOCOR/EPIC VALVE
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
3
PMA Approval
P
06
0025
3F AORTIC BIOPROSTHESIS, MODEL 1000
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
3
PMA Approval
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
3
PMA Approval
P
04
0021
BIOCOR/EPIC VALVE
3
PMA Approval
P
06
0025
3F AORTIC BIOPROSTHESIS
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS, MODELS 305 AND 310
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT, MODEL 150
3
PMA Approval
P
06
0025
3F AORTIC BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK LOW POROSITY AND MOFIFIED ORIFICE VALVED CONDUIT
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT MODEL 150
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
3
PMA Approval
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
3
PMA Approval
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
3
PMA Approval
P
04
0021
ST. JUDE MEDICAL BIOCOR AND BIOCOR SUPRA VALVES
3
PMA Approval
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
04
0021
BIOCOR & BIOCOR SUPRA VALVES, EPIC & EPIC SUPRA VALVES
3
PMA Approval
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
10
0029
TRIFECA VALVE
3
PMA Approval
P
10
0029
TRIFECTA HEART VALVE
3
PMA Approval
P
04
0021
ST JUDE MEDICAL BIOCOR/BIOCOR/SUPRA/EPIC/EPIC SUPRA HEART VALVES
3
PMA Approval
P
04
0021
EPIC VALVE
3
PMA Approval
P
06
0025
3F AORTIC BIOPROSTHESIS
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
04
0021
BIOCOR & EPIC VALVES
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT
3
PMA Approval
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
97
0031
FREESTYLE AORIC ROOT BIOPROSTHESIS MODELS 995, 995CS AND 995MS
3
PMA Approval
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS MODELS 305 AND 310
3
PMA Approval
P
79
0007
HANCOCK I LOW POROSITY AND MIDIFIED ORIFICE VALVED CONDUIT MODEL 105
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
10
0029
TRIFECTA VALVE
3
PMA Approval
P
10
0029
ST JUDE MEDICAL TRIFECTA VALVE
3
PMA Approval
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
3
PMA Approval
P
97
0031
FREESTYLE AORTICROOT BIOPROSTHESIS
3
PMA Approval
P
04
0021
ST. JUDE MEDICAL BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VLAVES
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
04
0021
BIOCOR AND BIOCOR SUPRA VALVES
3
PMA Approval
P
79
0007
HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT MODEL 150
3
PMA Approval
P
97
0031
AORTIC ROOT BIOPROSTHESIS MODELS 995, 995CS, 995MS
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS MODELS 995/995CS/995MS
3
PMA Approval
P
79
0007
HANCOCK I MODIFIED ORIFICE VALVED CONDUIT MODEL 150
3
PMA Approval
P
04
0021
ST JUDE MEDICAL BIOCOR/BIOCOR/SUPRA/EPIC/EPIC SUPRA HEART VALVES
3
PMA Approval
P
04
0021
ST JUDE MEDICAL BIOCOR/BIOCOR SUPRA EPIC/EPIC SUPRA VALVES
3
PMA Approval
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT MODEL 150
3
PMA Approval
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS MODEL 1000
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS MODEL 100
3
PMA Approval
P
79
0007
HANCOCK I LOW POROSITY & MODIFIED ORIFICE VALVED CONDUIT MODEL 150
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS MODELS 995/955CS/995MS
3
PMA Approval
P
79
0007
HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT, MODELS 105 AND 150
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
04
0021
SJM BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES
3
PMA Approval
P
04
0021
ST. JUDE MEDICAL BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK I LOW POROSITY & MODIFIED ORIFICE VALVED CONDUIT
3
PMA Approval
P
04
0021
ST JUDE MEDICAL BIOCOR/BIOCOR SUPRA/EPIC/EPIC SUPRA HEART VALVES
3
PMA Approval
P
04
0021
SJM BIOCOR/BIOCOR SUPRA VALVES
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS MODEL 1000
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX
3
PMA Approval
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS
3
PMA Approval
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS
3
PMA Approval
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS
3
PMA Approval
P
04
0021
SJM BIOCOR VALVE & SUPRA VALVE
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
04
0021
BIOCOR VALVE AND BIOCOR SUPRA VALVE\
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT
3
PMA Approval
P
04
0021
SJM BIOCOR VALVE AND SJM BIOCOR SUPRA VALVE
3
PMA Approval
P
79
0007
HANCOCK MO VALVED CONDUITS, MODEL 150
3
PMA Approval
P
04
0021
ST. JUDE MEDICAL BIOCOR VALVE AND BIOCOR SUPRA VALVE
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROTHESIS MODEL 995
3
PMA Approval
P
04
0021
ST. JUDE MEDICAL BIOCOR VALVE AND BIOCOR SUPRA VALVE
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT, MODEL 150
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS
3
PMA Approval
P
97
0030
ST JUDE MEDICAL TORONTO SPV VALVE, MODEL SPA-101
3
PMA Approval
P
04
0021
SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE
3
PMA Approval
P
97
0031
FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, SIZE 29 MM
3
PMA Approval
P
97
0031
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
97
0031
FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY, MODEL 995MS
3
PMA Approval
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
97
0030
ST JUDE TORONTO SPV VALVE
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE, MODIFIED ORIFICE II AORTIC BIOPROSTHESES
3
PMA Approval
P
97
0031
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
97
0031
MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE PORCINE BIOPROSTHETIC HEART VALVE
3
PMA Approval
P
97
0030
TORONTO SPV VALVE
3
PMA Approval
P
97
0031
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
97
0031
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
97
0031
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE PORCINE BIOPROSTHETIC HEART VALVE
3
PMA Approval
P
97
0031
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
97
0031
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
3
PMA Approval
P
97
0030
TORONTO SPV VALVE
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE II AORTIC BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS MODEL 250
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE AORTIC BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
3
PMA Approval
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
3
PMA Approval
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
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
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
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 20 June 2025 at 11:06 pm
CV
/
CV-misc
/
LWR
/
P970030
View Source
ST JUDE MEDICAL TORONTO SPV VALVE, MODEL SPA-101
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
St. Jude Medical, Inc.
Trade Name
TORONTO SPV VALVE
Generic Name
heart-valve, non-allograft tissue
Decision Date
11/4/1997
Days to Decision
120 days
Decision Code
APWD
FDA Decision
Withdrawal after 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
P
17
0006
AVALUS(TM) BIOPROSTHESIS
P
15
0048
EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)
P
15
0036
EDWARDS INTUITY ELITE VALVE SYSTEM
P
15
0011
PERCEVAL SUTURELESS HEART VALVE
P
13
0011
FREEDOM SOLO STENTLESS HEART VALVE
P
10
0029
ST JUDE MEDICAL TRIFECTA VALVE
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
04
0021
SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE
P
97
0031
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
15
0048
Edwards INSPIRIS RESILIA Aortic Valve
P
15
0048
KONECT RESILIA Aortic Valved Conduit (AVC)
P
04
0021
Epic and Epic Supra Tissue Heart Valves
P
15
0048
RESILIA Solutions System
P
15
0048
KONECT RESILIA Aortic Valved Conduit (AVC)
P
15
0011
Perceval Sutureless Heart Valve, Perceval PLUS
P
97
0031
Freestyle Bioprosthesis
P
79
0007
Hancock Modified Orifice Valved Conduit
P
79
0007
Hancock Modified Orifice Valved Conduit
P
97
0031
Freestyle Bioprosthesis
P
15
0036
EDWARDS INTUITY Elite Valve
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve
P
04
0021
Biocor, Biocor Supra, Epic and Epic Supra Tissue Heart Valves
P
17
0006
Avalus Bioprosthesis
P
15
0036
EDWARDS INTUITY Elite Valve
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valv
P
17
0006
Avalus Bioprosthesis
P
15
0011
Perceval Sutureless Heart Valve
P
04
0021
Biocor, Biocor Supra, Epic, Epic Supra
P
10
0029
Trifecta and Trifecta Valve with Glide Technology
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valv
P
15
0036
EDWARDS INTUITY Elite Delivery System
P
17
0006
Avalus Bioprosthesis
P
15
0048
Edwards Pericardial Aortic Bioprosthesis
P
15
0048
KONECT RESILIA Aortic Valved Conduit AVC
P
15
0011
Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve
P
04
0021
Biocor, Biocor Supra, Epic, and Epic Supra Valves
P
15
0036
Edwards INTUITY Elite Tube Extrusion
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve
P
15
0036
EDWARDS INTUITY Elite Valve
P
15
0011
Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve
P
13
0011
Solo Smart Heart Valve
P
15
0036
EDWARDS INTUITY Elite Valve System
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Edwards pericardial Mitral Bioprosthesis and Edwards INSPIRIS RESILIA Aortic V
P
15
0036
EDWARDS INTUITY Elite Aortic Valve
P
15
0011
Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve
P
13
0011
Solo Smart Heart Valve
P
15
0048
Edwards Pericardial Aortic Bioprosthesis
P
15
0036
EDWARDS INTUITY Elite Valve
P
15
0011
Perceval Sutureless Heart Valve
P
79
0007
Hancock Valved Conduit Modified Orifice
P
17
0006
Avalus
P
97
0031
Freestyle Bioprosthesis
P
10
0029
Trifecta and Trifecta GT Heart Valves
P
04
0021
Biocor, Biocor Supra, Epic and Epic Supra Heart Valves
P
15
0048
Edwards Pericardial Aortic Bioprostheses and Edwards Inspiris Resilia Aortic Valve
P
15
0036
Edwards Intuity Valves and Delivery Systems
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Pericardial Mitral Bioprosthesis, and Inspiris Resilia Aortic Valve
P
15
0036
Edwards Intuity Elite Valve System
P
06
0038
Mitroflow Aortic Pericardial Heart Valve
P
15
0036
Edwards Intuity Elite Valve System
P
15
0048
Edwards Inspiris Resilia Aortic Valve
P
15
0036
Edwards Intuity Elite Delivery System
P
15
0036
Edwards Intuity Elite Valve System
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Valve, and Edwards Pericardial Mitral Bioprosthesis
P
15
0036
Edwards Intuity Elite Valve
P
15
0048
Edwards INSPIRIS RESILIA Aortic Valve
P
15
0036
Edwards Intuity Elite Valve System
P
15
0048
Edwards Pericardial Aortic/Mitral Bioprosthesis and Edwards Inspiris Resilia Aortic Valve
P
17
0006
Avalus Bioprosthesis
P
17
0006
Avalus Bioprosthesis
P
97
0031
Freestyle Bioprosthesis
P
79
0007
Hancock Valved Conduit
P
17
0006
Avalus Bioprosthesis
P
15
0048
Edwards Pericradial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve
P
15
0036
Edwards Intuity Elite Valve System
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Pericardial Mitral Bioprosthesis, and Inspiris Resilia Aortic Valve
P
17
0006
Avalus Bioprosthesis
P
10
0029
Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT)
P
04
0021
Biocor, Biocor Supra, Epic, and Epic Supra Valves
P
17
0006
Avalus Bioprosthesis
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprothesis
P
04
0021
Biocor and Epic Valves
P
10
0029
Trifecta and Trifecta GT surgical Heart Valve
P
15
0011
Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve
P
13
0011
Solo Smart Heart Valve
P
10
0029
Trifecta/Trifecta GT Valves
P
04
0021
Biocor/Epic Valves
P
15
0048
Edwards Pericardial Aortic Bioprosthesis
P
15
0036
EDWARDS INTUITY Elite Valve System
P
97
0031
Freestyle Aortic Root Bioprosthesis
P
79
0007
Hancock Valved Conduit LP
P
17
0006
Avalus Bioprosthesis
P
04
0021
Biocor Valve, Supra Valve; Epic Valve, Supra
P
17
0006
Avalus Bioprosthesis
P
15
0011
Perceval Heart Valve
P
04
0021
Biocor, Biocor Supra, Epic, Epic Supra Valves
P
15
0011
Perceval Heart Valve
P
15
0048
Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve
P
17
0006
Medtronic CoreValve Evolut PRO TAV, and Avalus Bioprosthesis
P
15
0048
Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve
P
15
0036
EDWARDS INTUITY Elite Valve System
P
15
0036
EDWARDS INTUITY ELITE Valve/Delivery System
P
15
0036
EDWARDS INTUITY Elite Valve System
P
15
0048
Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve
P
15
0036
EDWARDS INTUITY Elite Valve System
P
15
0048
Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve
P
10
0029
Trifecta Valve with Glide Technology (Trifecta GT) Trifecta Valve.
P
15
0048
Edwards Pericardial Mitral Bioprosthesis
P
79
0007
Hancock Valved Conduit Modified Orifice
P
10
0029
Trifecta Valve with Glide Technology (Trifecta GT)
P
10
0029
Trifecta Valve / Trifecta Valve with Glide Technology (Trifecta GT )
P
15
0048
Edwards Pericardial Aortic Bioprosthesis / Edwards Inspiris Resilia Aortic Valve
P
15
0048
Edwards Pericardial Mitral Bioprosthesis, Model 11000M
P
17
0006
Avalus Bioprosthesis
P
15
0036
EDWARDS INTUITY Elite Valve System
P
15
0036
EDWARDS INTUITY ELITE Valve System
P
15
0048
Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis
P
06
0038
Mitroflow Aortic Pericardial Heart Valve
P
79
0007
Hancock Modified Orifice Valved Conduit
P
15
0048
Edwards Pericardial Aortic Bioprosthesis
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Model 11500A
P
15
0036
EDWARDS INTUITY Valve System
P
15
0048
Edwards Pericardial Aortic Bioprosthesis/ Edwards INSPIRIS RESILIA Aortic Valve
P
04
0021
St.Jude Medical Biocor, Epic and Epic Supra Valves
P
10
0029
Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT )
P
15
0048
Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis
P
15
0036
EDWARDS INTUITY ELITE Valve System
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Edwards Inspiris Resilia Aortic Valve
P
15
0036
Edwards Intuity Elite Valve System, Aortic Valve Model 8300AB and Delivery System Model 8300DB
P
79
0007
Hancock Modified Orifice Valved Conduit
P
97
0031
Freestyle Aortic Root Bioprosthesis
P
10
0029
Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT)
P
04
0021
Biocor Valve, Epic Valve, Epic Supra Valve
P
15
0048
Edwards Pericardial Aortic Bioprothesis, Inspiris Resilia Aortic Valve
P
15
0036
Edwards Intuity Elite Valve System
P
10
0029
Trifecta Valve/Trifecta Valve with Glide Technology (Trifecta GT)
P
15
0036
Edwards Intuity Elite Valve System
P
06
0038
Mitroflow Aortic Pericardial Heart Valve
P
15
0048
Edwards Pericardial Aortic Bioprosthesis, Edwards Inspiris Resilia Aortic Valve
P
15
0036
Edwards Intuity Elite Valve System
P
15
0048
Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve
P
15
0036
Edwards Intuity Elite Valve System
P
15
0048
Edwards Pericardial Aortic Bioprosthesis (Resilia tissue)
P
15
0011
Perceval Sutureless Heart Valve
P
13
0011
Solo Smart Stentless Heart Valve
P
15
0048
Edwards Pericardial Aortic Bioprosthesis
P
15
0048
Edwards Pericardial Aortic Bioprosthesis and Inspiris Resilia Aortic
P
15
0048
INSPIRIS RESILIA Aortic Valve
P
10
0029
Trifecta and Trifecta GT
P
10
0029
Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT)
P
15
0011
Perceval Sutureless Heart Valve
P
15
0036
EDWARDS INTUITY ELITE Valve System
P
15
0048
Edwards Pericardial Aortic Bioprosthesis (RESILIA tissue)
P
04
0021
Biocor and Epic Heart Valves
P
10
0029
Trifecta Heart Valves
P
15
0048
Edwards Pericardial Aortic Bioprosthesis
P
15
0036
EDWARDS INTUITY Elite Valve System
P
15
0036
EDWARDS INTUITY Elite Valve System, Aortic Valve and Delivery System
P
97
0031
Freestyle Aortic Root Bioprosthesis
P
79
0007
Hancock Modified Orifice Valved Conduit
P
15
0048
Inspiris Resilia Aortic Valve
P
04
0021
Biocor Heart Valve
P
10
0029
Trifecta Heart Valve
P
17
0006
Avalus Bioprosthesis, Model 400
P
97
0031
Freestyle Bioprosthesis
P
79
0007
Hancock Modified Orifice Valved Conduit
P
15
0048
Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve
P
15
0036
EDWARDS INTUITY ELITE Valve System
P
15
0048
RESILIA Aortic Valve
P
15
0036
EDWARDS INTUITY ELITE Valve System
P
15
0048
Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis
P
10
0029
Trifecta Valve with Glide Technology (Trifecta GT)
P
17
0006
Avalus Bioprosthesis
P
17
0006
Avalus
P
97
0031
Freestyle Bioprosthesis
P
97
0031
Freestyle Bioprosthesis
P
17
0006
Avalus Bioprosthesis Valve
P
79
0007
Hancock Modified Orific Valved Conduit.
P
04
0021
Biocor and Epic Heart Valves
P
15
0048
Edwards Pericardial Aortic Bioprosthesis
P
15
0048
Edwards Pericardial Aortic Bioprosthesis/Inspiris Resilia Aortic Valve
P
15
0036
Edwards Intuity Elite Valve System
P
15
0036
EDWARDS INTUITY Elite Valve System
P
15
0036
EDWARDS INTUITY ELITE Valve System
P
15
0048
Edwards Pericardial Aortic Bioprosthesis
P
97
0031
Freestyle Bioprosthesis, Model 995, 995SC and 995MS
P
79
0007
Hancock Modified Orifice (MO) Valved Conduit, Model 150
P
17
0006
AVALUS(TM) BIOPROSTHESIS
P
15
0036
Edwards INTUITY Elite Valve System
P
15
0011
Perceval Sutureless Heart Valve
P
15
0036
EDWARDS INTUITY ELITE Valve System
P
15
0036
EDWARDS INTUITY Valve System
P
15
0048
EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)
P
15
0036
Intuity Elite Valve System
P
15
0036
EDWARDS INTUITY VALVE SYSTEM
P
15
0036
Edwards Intuity Valve System
P
15
0036
Edwards Intuity Elite Valve & Delivery System
P
15
0036
EDWARDS INTUITY Valve System
P
15
0036
EDWARDS INTUITY Valve System
P
15
0036
EDWARDS INTUITY VALVE SYSTEM
P
15
0036
EDWARDS INTUITY Elite Valve System
P
10
0029
Trifecta Valve with Glide
P
97
0031
Freestyle Bioprosthesis, Models 995, 995CS and 995MS
P
15
0011
Perceval Sutureless Heart Valve
P
79
0007
Hancock Valved Conduit
P
97
0031
Freestyle Bioprosthesis
P
15
0036
EDWARDS INTUITY ELITE VALVE SYSTEM
P
15
0011
PERCEVAL SUTURELESS HEART VALVE
P
15
0011
PERCEVAL SUTURELESS HEART VALVE
P
15
0036
EDWARDS INTUITY ELITE VALVE SYSTEM (AORTIC VALVE MODEL 8300AB)
P
97
0031
MEDTRONIC FREESTYLE BIOPROSTHESIS
P
10
0029
TRIFECTA VALVE, VALVE WITH GLIDE
P
04
0021
SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE
P
15
0036
EDWARDS INTUITY ELITE VALVE SYSTEM
P
15
0011
PERCEVAL HEART VALVE
P
10
0029
ST JUDE MEDICAL TRIFECTA VALVE
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
P
04
0021
SJM BIOCOR AND EPIC VALVES
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
15
0011
PERCEVAL SUTURELESS HEART VALVE
P
13
0011
SOLO SMART STENTLESS HEART VALVE
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
15
0036
EDWARDS INTUITY ELITE VALVE SYSTEM
P
04
0021
SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE
P
10
0029
BIOCOR VALVE, SUPRA VALVE; EPIC VALVE, SUPRA VALVE; TRIFECTA VALVE, TRIFECTA VALVE WITH GLIDE TECHONOLOGY (TRIFECTA GT)
P
04
0021
BIOCOR VALVE, SUPRA VALVE; EPIC VALVE, SUPRA VALVE; TRIFECTA VALVE, TRIFECTA VALVE WITH GLIDE TECHONOLOGY (TRIFECTA GT)
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
P
15
0011
PERCEVAL SUTURELESS HEART VALVE
P
79
0007
THE HANCOCK VALVED CONDUIT MODIFIED ORIFICE (MODEL 105)
P
13
0011
FREEDOM SOLO STENTLESS HEART VALVE
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
15
0011
PERCEVAL SUTURELESS HEART VALVE
P
10
0029
TRIFECTA VALVE WITH GLIDE TECHNOLOGY
P
13
0011
THE SOLO SMART STENTLESS HEART VALVE
P
15
0011
THE PERCEVAL SUTURELESS HEART VALVE
P
15
0011
PERCEVAL SUTURELESS HEART VALVE
P
13
0011
SOLO SMART STENTLESS HEART VALVE (SOLO SMART)
P
06
0038
Crown PRT Aortic Pericardial Heart Valve with PR Treatment
P
15
0011
PERCEVAL SUTURELESS HEART VALVE
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE VALUED CONDUIT
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
06
0025
3F AORTIC BIOPROSTHESIS
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
10
0029
TRIFECTA VALVE
P
13
0011
SOLO SMART STENTLESS HEART VALVE
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
99
0064
MOSAIC PORCINE BIOPROSTHETIC HEART VALVE
P
10
0029
TRIFECTA VALVE
P
04
0021
BIOCOR, EPIC AND EPIC SUPRA VALVE
P
06
0038
MTROFLOW AORTIC PERICARDIAL HEART VALVE
P
10
0029
TRIFECTA VALVE
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART CALVE WITH PHOSPHOLIPID REDUCTION TREATMENT
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS(MODELS 995, 995CS, 995MS)
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS- (MODELS 305. 310)
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT-(MODEL 150)
P
10
0029
TRIFECTA VALVE
P
99
0064
MOSIAC PORCINE BIOPOROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
06
0025
MEDTRONIC 3F AORTIC BIOPROSTHESIS MODEL 1000
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
P
13
0011
FREEDOM SOLO STENTLESS HEART VALVE
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
10
0029
TRIFECTA VALVE
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL
P
04
0021
BIOCOR AND EPIC VALVE
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
79
0007
HANCOCK MODIFIED ORIFICE (MO) VALUED CONDUIT
P
10
0029
TRIFECTA VALVE
P
04
0021
BIOCOR/EPIC VALVE
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
P
06
0025
3F AORTIC BIOPROSTHESIS, MODEL 1000
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
P
04
0021
BIOCOR/EPIC VALVE
P
06
0025
3F AORTIC BIOPROSTHESIS
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS, MODELS 305 AND 310
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT, MODEL 150
P
06
0025
3F AORTIC BIOPROSTHESIS
P
79
0007
HANCOCK LOW POROSITY AND MOFIFIED ORIFICE VALVED CONDUIT
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT MODEL 150
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
99
0064
MOSAIC PORCINE BIOPROSTHESIS
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV)
P
04
0021
ST. JUDE MEDICAL BIOCOR AND BIOCOR SUPRA VALVES
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
P
10
0029
TRIFECTA VALVE
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
10
0029
TRIFECTA VALVE
P
10
0029
TRIFECTA VALVE
P
10
0029
TRIFECTA VALVE
P
04
0021
BIOCOR & BIOCOR SUPRA VALVES, EPIC & EPIC SUPRA VALVES
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
10
0029
TRIFECA VALVE
P
10
0029
TRIFECTA HEART VALVE
P
04
0021
ST JUDE MEDICAL BIOCOR/BIOCOR/SUPRA/EPIC/EPIC SUPRA HEART VALVES
P
04
0021
EPIC VALVE
P
06
0025
3F AORTIC BIOPROSTHESIS
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
10
0029
TRIFECTA VALVE
P
10
0029
TRIFECTA VALVE
P
04
0021
BIOCOR & EPIC VALVES
P
10
0029
TRIFECTA VALVE
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
79
0007
HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
P
10
0029
TRIFECTA VALVE
P
97
0031
FREESTYLE AORIC ROOT BIOPROSTHESIS MODELS 995, 995CS AND 995MS
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS MODELS 305 AND 310
P
79
0007
HANCOCK I LOW POROSITY AND MIDIFIED ORIFICE VALVED CONDUIT MODEL 105
P
10
0029
TRIFECTA VALVE
P
10
0029
TRIFECTA VALVE
P
10
0029
TRIFECTA VALVE
P
10
0029
ST JUDE MEDICAL TRIFECTA VALVE
P
99
0064
MOSIAC PORCINE BIOPROSTHESIS
P
97
0031
FREESTYLE AORTICROOT BIOPROSTHESIS
P
04
0021
ST. JUDE MEDICAL BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VLAVES
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
04
0021
BIOCOR AND BIOCOR SUPRA VALVES
P
79
0007
HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT MODEL 150
P
97
0031
AORTIC ROOT BIOPROSTHESIS MODELS 995, 995CS, 995MS
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS MODELS 995/995CS/995MS
P
79
0007
HANCOCK I MODIFIED ORIFICE VALVED CONDUIT MODEL 150
P
04
0021
ST JUDE MEDICAL BIOCOR/BIOCOR/SUPRA/EPIC/EPIC SUPRA HEART VALVES
P
04
0021
ST JUDE MEDICAL BIOCOR/BIOCOR SUPRA EPIC/EPIC SUPRA VALVES
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT MODEL 150
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS MODEL 1000
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS MODEL 100
P
79
0007
HANCOCK I LOW POROSITY & MODIFIED ORIFICE VALVED CONDUIT MODEL 150
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS MODELS 995/955CS/995MS
P
79
0007
HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
79
0007
HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT, MODELS 105 AND 150
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
04
0021
SJM BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES
P
04
0021
ST. JUDE MEDICAL BIOCOR, BIOCOR SUPRA, EPIC AND EPIC SUPRA HEART VALVES
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
79
0007
HANCOCK I LOW POROSITY & MODIFIED ORIFICE VALVED CONDUIT
P
04
0021
ST JUDE MEDICAL BIOCOR/BIOCOR SUPRA/EPIC/EPIC SUPRA HEART VALVES
P
04
0021
SJM BIOCOR/BIOCOR SUPRA VALVES
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS MODEL 1000
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS
P
06
0025
ATS 3F AORTIC BIOPROSTHESIS
P
04
0021
SJM BIOCOR VALVE & SUPRA VALVE
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
04
0021
BIOCOR VALVE AND BIOCOR SUPRA VALVE\
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
06
0038
MITROFLOW AORTIC PERICARDIAL HEART VALVE
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT
P
04
0021
SJM BIOCOR VALVE AND SJM BIOCOR SUPRA VALVE
P
79
0007
HANCOCK MO VALVED CONDUITS, MODEL 150
P
04
0021
ST. JUDE MEDICAL BIOCOR VALVE AND BIOCOR SUPRA VALVE
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS
P
97
0031
FREESTYLE AORTIC ROOT BIOPROTHESIS MODEL 995
P
04
0021
ST. JUDE MEDICAL BIOCOR VALVE AND BIOCOR SUPRA VALVE
P
79
0007
HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT, MODEL 150
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS
P
97
0030
ST JUDE MEDICAL TORONTO SPV VALVE, MODEL SPA-101
P
04
0021
SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE
P
97
0031
FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, SIZE 29 MM
P
97
0031
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
97
0031
FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY, MODEL 995MS
P
97
0031
FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
97
0030
ST JUDE TORONTO SPV VALVE
P
79
0007
HANCOCK MODIFIED ORIFICE, MODIFIED ORIFICE II AORTIC BIOPROSTHESES
P
97
0031
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
97
0031
MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE PORCINE BIOPROSTHETIC HEART VALVE
P
97
0030
TORONTO SPV VALVE
P
97
0031
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
97
0031
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
97
0031
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE PORCINE BIOPROSTHETIC HEART VALVE
P
97
0031
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
97
0031
MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
P
97
0030
TORONTO SPV VALVE
P
79
0007
HANCOCK MODIFIED ORIFICE II AORTIC BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS MODEL 250
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE VALVED CONDUIT
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE AORTIC BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
P
79
0007
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
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
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)
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
/
LWR
/
P970030
View Source
ST JUDE MEDICAL TORONTO SPV VALVE, MODEL SPA-101
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
St. Jude Medical, Inc.
Trade Name
TORONTO SPV VALVE
Generic Name
heart-valve, non-allograft tissue
Decision Date
11/4/1997
Days to Decision
120 days
Decision Code
APWD
FDA Decision
Withdrawal after approval