Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- QODExtracorporeal Circuit And Accessories For Long Term Respiratory Cariodpulmonary FailureNProduct Code
- QRJLaser-Powered Inferior Vena Cava Filter Retrieval Catheter2Product Code
- KPKMarker, Ostia, Aorto-Saphenous Vein2Product Code
- DSQVentricular (Assist) Bypass3Product Code
- FZCProsthesis, Arterial Graft, Bovine Carotid Artery3Product Code
- LOTPulse-Generator, Program Module3Product Code
- LOZArtificial Heart3Product Code
- LPASystem, Esophageal Pacing3Product Code
- LPBCardiac Ablation Percutaneous Catheter3Product Code
- P050029HELIOS II ABLATION CATHETERAPPRPMA Approval
- P040036NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERAPPRPMA Approval
- P040014IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATORAPPRPMA Approval
- P0200457F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEMAPPRPMA Approval
- P000020STINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLEAPPRPMA Approval
- P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATORAPPRPMA Approval
- P990054CHILLI COOLED ABLATION SYSTEMAPWDPMA Approval
- P960016LIVEWIRE(R) CARDIAC ABLATION SYSTEMAPPRPMA Approval
- P980003CHILLI COOLED RF ABLATION SYSTEMAPPRPMA Approval
- P950005WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETERAPPRPMA Approval
- P950005CELSIUS DS, NAVISTAR DS, EZ STEER DS and CELSIUS FLTR3PMA Approval
- P020045Freezor, Freezor Xtra and Freezor MAX Cardiac Cryoablation Catheter, Electrical Umbilical and Coax Umbilical cable3PMA Approval
- P920047IntellaNav ST3PMA Approval
- P040036THERMOCOOL SMARTTOUCH® Uni-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH® Bi-Directional Navigation Catheter3PMA Approval
- P020045Freezor Xtra Cardiac Cryoablation Catheter3PMA Approval
- P920047IntellaNav ST Ablation Catheter, Blazer II Temperature Ablation Catheter, Blazer II HTD Temperature Ablation Catheter, a3PMA Approval
- P990071Smartablate System Interface Cables3PMA Approval
- P040036EZ Steer ThemoCool Nav Bi-Directional Electrophysiology Catheter, Navistar ThermoCool Catheter, Navistar RMT ThermoCool,3PMA Approval
- P950005Celsius FLTR (Flutter) Catheter, Celsius Electrophysiology Catheter, Webster Electrophysiology Catheter EZ Steer DS Bi-D3PMA Approval
- P0200457F Freezor Cardiac CryoablationCatheter and CCT.2 Cryoconsole System3PMA Approval
- P960016LiveWire TC Ablation Catheter and Safire Ablation Catheter3PMA Approval
- P040014Therapy Ablation Catheter, Therapy 4MM Thermistor Ablation Catheter, Therapy Bi-Directional Ablation Catheter3PMA Approval
- P950005Biosense Webster Cables, Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter,3PMA Approval
- P990071Biosense Webster Cables3PMA Approval
- P040036EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Ca3PMA Approval
- P990071THERMOCOOL™SMARTTOUCH, THERMOCOOL™SMARTTOUCH SF3PMA Approval
- P040036EZ STEER™THERMOCOOL, THERMOCOOL™SF NAV, THERMOCOOL™SF3PMA Approval
- P950005CELSIUS™, CELSIUS™DS, CELSIUS™RMT, CELSIUS™THERMOCOOL, CELSIUS3PMA Approval
- P040036Navistar Thermocool, EZ Steer Thermocool Nav Bi- Directional, Navistar RMT Thermocool, Thermocool SF Nav Bi-directional,3PMA Approval
- P950005Celsius, Celsius RMT, EZ Steer Bi-directional non nav3PMA Approval
- P040014Therapy and Therapy Dual-83PMA Approval
- P0200457F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter, 9F Freezor MAX Cardiac Cryoabla3PMA Approval
- P960016Livewire TC Steerable Electrophysiology Catheter, Safire Bi-directional Ablation Catheter3PMA Approval
- P040014Therapy Ablation Catheters3PMA Approval
- P040036Thermocool Smarttouch3PMA Approval
- P040036EZ Steer Thermocool, EZ Steer Thermocool Bi-Directional, Navistar Thermocool3PMA Approval
- P950005Celsius, Celsius Flutter, EZ Steer3PMA Approval
- P040036EZ Steer ThermoCool Nav Deflectable Diagnostic/Ablation Catheter3PMA Approval
- P040036ThermoCool SmartTouch SF Catheters3PMA Approval
- P930029RF Conductr, RF Contactr, RF Marinr, RF Marinr Unipolar, and RF Enhancr II3PMA Approval
- P930029Catheter RF Contactr, Catheter RF Enhancr II, RF Conductr MC, RF Marinr, RF Marinr 5F SC/ 5F SCXL, 5F SCXS and 5F SCXXL,3PMA Approval
- P040014Therapy Ablation Catheters3PMA Approval
- P960016Livewire TC Steerable Electrophysiology Catheter and Safire Bi-directional Ablation Catheter3PMA Approval
- P960016Livewire TC Ablation Catheter, Livewire TC Cables, Safire Ablation Catheter, Safire Cables3PMA Approval
- P040014Therapy Ablation Catheter3PMA Approval
- P990071SmartAblate Irrigation Tubing Set3PMA Approval
- P930029RF Conductr, RF Contactr, RF Marinr, and RF Enhancr II3PMA Approval
- P950005EZ Steer DS Bi-Directional Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiology Catheter3PMA Approval
- P930029RF Conductr, RF Contactr, RF Marinr, RF Enhancr II3PMA Approval
- P990071nGEN Pump3PMA Approval
- P040036THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter and THERMOCOOL SMARTTOUCH Navigation Catheter3PMA Approval
- P040036Thermocool Smarttouch3PMA Approval
- P960016Livewire TC Ablation Catheter, Livewire TC Cables, Safire Ablation Catheter, Safire Cables3PMA Approval
- P920047Blazer Prime XP cardiac ablation catheters3PMA Approval
- P980003Chilli II Cooled Ablation Catheter and Cable3PMA Approval
- P920047Blazer II Cardiac Ablation Catheter and Cable3PMA Approval
- P040036THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter, Navigation Catheter3PMA Approval
- P040014Therapy Ablation Catheter (including Bi-Directional Catheter) Therapy 4mm Thermistor Ablation Catheter3PMA Approval
- P960016Livewire TC Ablation Catheter and Safire Ablation Catheter3PMA Approval
- P040036EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Ca3PMA Approval
- P990071Biosense Webster Cables3PMA Approval
- P950005Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, EZ St3PMA Approval
- P960016Livewire TC Ablation Catheter3PMA Approval
- P040036Thermocool Smarttouch Bi-Directional Navigation Catheter, Thermocool Smarttouch SF Uni-Directional Navigation Catheter,3PMA Approval
- P040014Therapy Ablation Catheter, Therapy 4mm Thermistor Ablation Catheter and Therapy Bi-Directional Ablation Catheter3PMA Approval
- P020045Freezor Cardiac Cryoablation Catheter3PMA Approval
- P040036Thermocool Smart Touch Bi-Directional and Thermocool Smart Touch Electrophysiology3PMA Approval
- P950005Celsius Electrophysiology Catheter, Deflectable Tip Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiolog3PMA Approval
- P920047IntellaNav ST Temperature Ablation Catheter3PMA Approval
- P920047Blazer Prime HTD3PMA Approval
- P020045Freezor, Arctic Front Advance (AFA) CryoAblation Catheters3PMA Approval
- P920047IntellaNav ST3PMA Approval
- P980003Chilli II Cooled Ablation Catheter and Cable3PMA Approval
- P920047Blazer II Cardiac Ablation Catheter and Cable3PMA Approval
- P960016Livewire TC Ablation, Livewire TC Cables, Safire Ablation Catheter and Safire Cables3PMA Approval
- P020045Freezor Cardiac Cryoablation System3PMA Approval
- P040014Therapy Ablation , Therapy 4mm Thermistor Ablation Catheter3PMA Approval
- P920047Maestro 4000 Controller Firmware3PMA Approval
- P980003Maestro 4000 Controller Firmware3PMA Approval
- P960016LIVEWIRE(R) CARDIAC ABLATION SYSTEM3PMA Approval
- P040036EZ Steer Thermocool NAV Catheter and Navistar Thermocool3PMA Approval
- P950005Celsius Catheter3PMA Approval
- P930029Medtronic RF Ablation Catheters3PMA Approval
- P920047Blazer II XP, Blazer Prime HTD, Blazer Prime XP Cardiac Ablation Percutaneous Catheter3PMA Approval
- P990071CoolFlow Irrigation Tubing Set3PMA Approval
- P960016Livewire TC Ablation Catheter (Livewire TC)3PMA Approval
- P980003Chilli II3PMA Approval
- P920047Blazer II, Blazer II HTD, Blazer Prime HTD, IntellaNav ST3PMA Approval
- P040036ThermoCool SmartTouch SF Catheter3PMA Approval
- P990071SmartAblate Irrigation Pump, nGEN Pump Devices3PMA Approval
- P040036ThermoCool SmartTouch Uni-directional and ThermoCool SmartTouch Bi-directional navigation Catheter3PMA Approval
- P920047IntellaTip MiFi Xp Ablation Catheters, IntellaNsv MiFi XP Ablation Catheters and IntellaNav ST Ablation Catheters3PMA Approval
- P040014Electrophysiology Cable, Therapy Ablation Catheter3PMA Approval
- P040036ThermoCool SmartTouch SF Bi-Directional Navigation Catheter; ThermoCool SmartTouch SF Uni-Directional Navigation Cathete3PMA Approval
- P040036Navistar RMT Thermocool Catheter3PMA Approval
- P950005Celsius RMT Catheter; Navistar RMT Thermocool Catheter; Celsius RMT Thermocool Catheter; Navistar RMT Catheter3PMA Approval
- P960016Livewire TC Cables; Safire Ablation Catheter; Safire Cable3PMA Approval
- P980003Maestro 4000 Controller3PMA Approval
- P920047Maestro 4000 Controller3PMA Approval
- P040014Therapy Ablation Catheters3PMA Approval
- P960016Livewire TC Steerable Electrophysiology Catheter, Safire Bi-Directional Ablation Catheter3PMA Approval
- P920047IntellaNav ST3PMA Approval
- P930029RF Enhancr II Catheter3PMA Approval
- P920047Blazer II, Blazer II HTD, Blazer Prime HTD3PMA Approval
- P930029RF Marinr Catheters3PMA Approval
- P980003Chilli II Cooled Ablation Catheter and Cable3PMA Approval
- P920047Blazer II Cardiac Ablation Catheter and Cable3PMA Approval
- P930029RF Contactr, RF Enhancr II, RF Marinr, RF Conductr, Cardiac Ablation Percutaneous Catheters3PMA Approval
- P980003Chilli II Cooled Ablation Catheter and Cable3PMA Approval
- P920047Blazer II Cardiac Ablation Catheter and Cable3PMA Approval
- P990071nGEN Pump3PMA Approval
- P960016Livewire TC Ablation Catheter3PMA Approval
- P020045CryoConsole3PMA Approval
- P950005Webster Electrophysiology Catheter, Celsius Electrophysiology Catheter, Electrophysiology Catheter Deflectable braided t3PMA Approval
- P990071Smartablate Cable3PMA Approval
- P040036ThermoCool SmartTouch Uni-Bi-Directional Navigation Catheter3PMA Approval
- P020045Freezor Cardiac Cryoablation Catheter; Freezor Xtra Surgical Cardiac Cryoablation Device; Freezor MAX Cardiac Cryoablati3PMA Approval
- P920047Blazer II Cardiac Ablation Catheter and Cable3PMA Approval
- P980003Chilli II Cooled Ablation Catheter and Cable3PMA Approval
- P930029RF Contactr, RF Conductr and RF Marinr3PMA Approval
- P990071SmartAblate System3PMA Approval
- P020045Gen V CryoConsole3PMA Approval
- P020045Freezor Cardiac CryoAblation Catheter, Freezor Xtra Cardiac CryoAblation Catheter and Freezor MAX Cardiac CryoAblation3PMA Approval
- P960016LiveWire TC Steerable Electrophysiology Catheter3PMA Approval
- P960016LiveWire TC Steerable Electrophysiology Catheter3PMA Approval
- P950005WEBSTER Catheter / CELSIUS Catheter3PMA Approval
- P930029RF Marinr, Unipolar Mapping RF Marinr, RF Conductr MC, RF Enhancr, and RF Contactr3PMA Approval
- P960016Livewire TC Ablation Catheter / Safire Bi-Directional Catheter3PMA Approval
- P960016Livewire TC Steerable Electrophysiology Catheter, Safire Bi-Directional Ablation Catheter3PMA Approval
- P040014Therapy Ablation Catheters3PMA Approval
- P930029RF Conductr MC; RF Marinr 5Fr; RF Marinr 7Fr; and Unipolar Mapping RF Marinr 7Fr3PMA Approval
- P920047Blazer II Cardiac Ablation Catheter and Cable3PMA Approval
- P980003Chilli II Cooled Ablation Catheter and Cable3PMA Approval
- P920047IntellaNav St Cardiac Ablation Catheter3PMA Approval
- P020045Freezor Cardiac Cryoablation Catheter (4-mm tip), Freezor Xtra Surgical Cardiac Cryoablation Device (6-mm tip), Freezor3PMA Approval
- P040036ThermoCool SmartTouch Uni-Directional Navigation Catheter3PMA Approval
- P040036ThermoCool Smart Touch SF Catheters3PMA Approval
- P920047Blazer II Cardiac Ablation Catheter and Cable3PMA Approval
- P980003Chilli II Cooled Ablation Catheter and Cable3PMA Approval
- P020045Freezor Cardiac CryoAblation System3PMA Approval
- P920047Blazer II Cardiac Ablation System3PMA Approval
- P980003Chilli II Cooled RF Ablation System3PMA Approval
- P960016Safire Bi-Directional Ablation Catheters, Livewire TC Ablation Catheter3PMA Approval
- P040036Navistar Thermocool Deflectable Diagnostics/Ablation Catheter3PMA Approval
- P950005Webster Diag/ Ablation Deflectable Tip Catheter3PMA Approval
- P990071Stockert 70 Radio Frequency Ablation Generator3PMA Approval
- P040036Navistar Thermo Cool Deflectable Diagnostic/Ablation Catheter3PMA Approval
- P950005Webster Diag./Ablation Deflectable Tip Catheter3PMA Approval
- P920047Blazer II HTD / Blazer Prime HTD3PMA Approval
- P980003Chilli II3PMA Approval
- P950005WEBSTER CATHETER, CELSIUS THERMOCOOL Catheter, CELSIUS Catheter3PMA Approval
- P980003Chilli II Cooled Ablation System3PMA Approval
- P020045Freezor CryoAblation System (CryoConsole)3PMA Approval
- P920047Blazer II HTD, Blazer Prime HTD3PMA Approval
- P980003Chill II3PMA Approval
- P980003Chilli II Cooled RF Ablation system3PMA Approval
- P920047Blazer II Cardiac Ablation System3PMA Approval
- P990071SmartAblate System Foot Pedal.3PMA Approval
- P980003Chilli II Coole dAblation Catheter and Cable3PMA Approval
- P920047Blazer II Cardiac Ablation Catheter and Cable3PMA Approval
- P040036NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER3PMA Approval
- P990071BIOSENSE WEBSTER CABLES3PMA Approval
- P950005WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER3PMA Approval
- P950005EZ Steer Non- Navigational 8mm (DS) ; EZ Steer DS ; EZ Steer Non-Navigational 4mm (TC) & (THR) ; Celsius 4mm Bi-Dir T ;3PMA Approval
- P040036EZ Steer Smart Touch; Thermocooll ST Uni3PMA Approval
- P950005Therapeutic Catheters3PMA Approval
- P980003Chilli II TM Cooled Ablation Catheter and Cable3PMA Approval
- P920047Blazer IITM Cardiac Ablation Catheter and Cable3PMA Approval
- P920047Blazer (II, II HTD, Primie HTD)3PMA Approval
- P980003Chilli Cooled RF Ablation System3PMA Approval
- P950005WEBSTER CATHETER; CELSIUS THERMOCOOL CATHETER; CELSIUS CATHETER;; CELSIUS RMT CATHETER3PMA Approval
- P990071Stockert 70 RF Generator Foot Pedal3PMA Approval
- P980003Chilli II Cooled Ablation Catheter3PMA Approval
- P040014Therapy Ablation Catheter including Bi-Directional catheter and Therapy 4mm Thermistor Ablation Catheter3PMA Approval
- P960016Livewire TC™ Ablation Catheter and Safire™ Bi-Directional Ablation Catheter3PMA Approval
- P920047Blazer II TM Cardiac Ablation Catheter and Cable3PMA Approval
- P980003Chilli II ™ Cooled Ablation Catheter and Cable3PMA Approval
- P020045Freezer Cardiac Cryoablation, Freezer Xtra Surgical Cardiac, Freezer MAX Surgical Cardiac3PMA Approval
- P980003Chilli II Cooled Ablation Catheter andCable3PMA Approval
- P920047Blazer II Cardiac Ablation Catheter and Cable3PMA Approval
- P020045Freezor Catheter, Freezor Xtra Catheter, Freezor MAX Surgical Device, Electrical umbilical cable, Coaxial umbilical cabl3PMA Approval
- P020045Coaxial Umbilical Cable3PMA Approval
- P020045Freezor CryoAblation System3PMA Approval
- P920047Blazer II, Blazer II HTD, Blazer Prime HTD3PMA Approval
- P930029Catheter RF Contactr, Catheter RF Enhancr II3PMA Approval
- P980003CHILLI II ABLATION CATHETER.3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETER /XTRA SUGICAL/ MAX SURGICAL CARDIA CRYOABLATION DEVICES, STERILE ACCESSORIES COAX3PMA Approval
- P930029RF ENHANCR II3PMA Approval
- P950005CELSIUS/DEFLECTABLE TIP ELECTROPHYSIOLOGY CATHETER3PMA Approval
- P040036THERMOCOOL SMART TOUCH BI-DIRECTIONAL AND ELECTROPHYSIOLOGY3PMA Approval
- P960016Livewire TC Steerable Electrophysiology Catheter3PMA Approval
- P040014Therapy Ablation Catheters3PMA Approval
- P020045FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE3PMA Approval
- P980003CHILLI II3PMA Approval
- P920047BLAZER II CARDIAC ABLATION CATHETER AND CABLE3PMA Approval
- P980003CHILLI COOLED ABLATION CATHETER AND CABLE3PMA Approval
- P030031THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER; THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAVIGATION CATHETE3PMA Approval
- P990071SMARTABLATE SYSTEM: SMARTABLATE RF GENERATOR AND REMOTE CONTROL, SMARTABLATE SYSTEM: SMARTABLATE IRRIGATION PUMP3PMA Approval
- P960016LIVEWIRE(R) CARDIAC ABLATION SYSTEM3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CATHETERS, FREEZOR MAX SURGICAL CATHETER3PMA Approval
- P040036THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER3PMA Approval
- P020045FREEZOR FAMILY CARDIAC CRYOABLATION CATHETERS3PMA Approval
- P920047BLAZER II, BLAZER II HTD TEMPERATURE ABLATION CATHETERS, BLAZER II XP, BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS3PMA Approval
- P960016LIVEWIRE TC ABLATION CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER3PMA Approval
- P040014THERAPY ABLATION CATHETER (INCLUDING BI-DIRECTIONAL) THERAPY 4MM THERMISTOR ABLATION CATHETER3PMA Approval
- P920047Blazer II, Blazer II HTD, Blazer Prime HTD3PMA Approval
- P980003CHILLI COOLED RF ABLATION SYSTEM3PMA Approval
- P960016LIVEWIRE(R) TC CARDIAC ABLATION SYSTEM3PMA Approval
- P930029RF MARINR CATHETERS, RF ENHANCER II CATHETERS, RF CONTRACTR CATHETERS AND RF CONDUCTR CATHETERS3PMA Approval
- P040014THERAPY CARDIAC ABLATION CATHETER3PMA Approval
- P960016LIVEWIRE CARDIAC ABLATION SYSTEM3PMA Approval
- P060019THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL PATH SP ABLATION CATHETE, SAFIRE BLU ABLATION CATHETER, SAFIRE BLU SP3PMA Approval
- P110016THERAPY COOL PATH DUO ABLATION, THERAPY COOL PATH SP ABLATION CATHETER,SAFIRE BLU DUO ABLATION CATHETER,SAFIRE BLU DUO S3PMA Approval
- P920047BLAZER PRIME HTD,BLAZER II,BLAZER II HTD TEMPERATURE ABLATION CATHETERS3PMA Approval
- P950005EZ Steer DS Bi-Directional Catheter,EZ Steer Bi-Directional CatheterABLATION, Celsius Flutter Bi-Directional Catheter3PMA Approval
- P040036THERMOCOOL SMART TOUCH UNI-DIRECTIONAL NAVIGATION CATHETER3PMA Approval
- P960016LIVEWIRE(R) CARDIAC ABLATION SYSTEM3PMA Approval
- P960016LIVEWIRE(R) CARDIAC ABLATION SYSTEM3PMA Approval
- P0200457F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM3PMA Approval
- P980003CHILLI COOLED RF ABLATION SYSTEM3PMA Approval
- P920047EPT-1000 CARDIAC ABLATION SYSTEM3PMA Approval
- P920047EPT-1000 CARDIAC ABLATION SYSTEM3PMA Approval
- P960016LIVEWIRE(R) CARDIAC ABLATION SYSTEM3PMA Approval
- P040014IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR3PMA Approval
- P110016FLEXABILITY ABLATION CATHETER3PMA Approval
- P960016LIVEWIRE TC ABLATION CATHETER, SAFIRE ABLATION CATHETER3PMA Approval
- P060019THERAPY COOL PATH ABLATION CATHETER AND IBI-1500T9 RF ABLATION GENERATOR3PMA Approval
- P110016THERAPY COOL PATH DUO,SAFIRE BLU DUO AND COOL PATH DUO,THERAPY COOL PATH DUO SP,SAFIRE BLU DUO SP,THERAY COOL FLEX CATHP3PMA Approval
- P060019THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP AND THERAPY COOL PATH SP ABLATION CATHETERS, AND 1500T9-CP RF GENERATORS3PMA Approval
- P040014THERAPY ABLATION CATHETERS3PMA Approval
- P960016LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER3PMA Approval
- P920047CHILLI II COOLED ABLATION SYSTEM3PMA Approval
- P980003CHILLI II COOLED ABLATION SYSTEM3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION SYSTEM3PMA Approval
- P930029RF MARINR 5F SC, RF MARINR 5F SCXL, RF MARINR 5F SCXS, RF MARINR 5F SCXXL3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION SYSTEM3PMA Approval
- P020045FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CRYOABLATION DEVICE3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CATHETER3PMA Approval
- P110016FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL) ; FLEXABILITY ABLATION CATHETER(UNI-DIRECTIONAL)3PMA Approval
- P920047BLAZER PRIME HTD, BLAZER II, BLAZER II HTD3PMA Approval
- P030031CELSIUS RMT THERMOCCOL CAT, CELSIUS THERMOCCOL CATH NAVISTAR & RMT THERMOCOOL CATHS,THERMOCOOL SF, SMARTTOUCH& NAV CATH3PMA Approval
- P950005BIOSENSE WEBSTER CABLES, CELSIUS CATHETER, CELSIUS RMT CATHETER, CLESIUS FLTR, DEFLECTABLE DISGNOSTIC/ABLATION CATHETER3PMA Approval
- P990071BIOSENSE WEBSTER CABLES3PMA Approval
- P990025BIOSENSE WEBSTER CABLES, EZ STEER NAV CATHETER, NAVISTAR CATHETER, NAVISTAR RMT CATHETER3PMA Approval
- P040036EZ STEER THERMOCOOL CATH, EZ STEER THERMOCOOL NAV CATH NAVISTAR RMT THERMOCOOL & THERMOCOOL CATH, THERMOCOOL SMARTTOUCH3PMA Approval
- P110016FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL) , FLEXABILITY ABLATION CATHETER (UNI-DIRECTIONAL)3PMA Approval
- P960016LIVEWIRE TC CARDIAC ABLATION SYSTEM3PMA Approval
- P020045FREEZOR CARDIAC CRYOBLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC CR3PMA Approval
- P030031CELSIUS THERMOCOOL, THERMOCOOL SF, NAVISTAR THERMOCOOL, THERMOCOOL SF NAV, THERMOCOOL SMARTTOUCH3PMA Approval
- P040036THERMOCOOL SMARTTOUCH3PMA Approval
- P990025NAVISTAR3PMA Approval
- P950005CELSIUS DS3PMA Approval
- P060019THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP, AND THERAPY COOL PATH SP ABLATION CATHETERS3PMA Approval
- P110016FLEXABILITY ABLATION CATHETER, THERAPY COOL PATH DUO, SAFIRE BLU DUO, COOL PATH DUO, SAFIRE DUO, THERAPY COOL PATH DUO3PMA Approval
- P960016LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER, SAFIRE BI-DIRECTIONAL ABLATION CATHETER3PMA Approval
- P040014THERAPY ABLATION CATHETERS3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER AND CABLE3PMA Approval
- P920047BLAZER II CARDIAC ABLATION CATHETER AND CABLE3PMA Approval
- P920047BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS3PMA Approval
- P020045CRYOABLATION SYSTEM3PMA Approval
- P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR3PMA Approval
- P980003CHILLI II COOLED ABLATION SYSTEM3PMA Approval
- P920047EPT-1000 CARDIAC ABLATION SYSTEM3PMA Approval
- P110016FLEXABILITY ABLATION CATHETERS (UNI-DIRECTIONAL),FLEXABILITY ABLATION CATHETERS (BI-DIRECTIONAL)3PMA Approval
- P110016THERAPY COOL FLEX AND FLEXABILITY ABLATION CATHETERS3PMA Approval
- P930029RF CONTACTR, RF ENHANCR II, RF MARINR, RF CONDUCTR.3PMA Approval
- P960016LIVEWIRE TC ABLATION CATHETER3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER3PMA Approval
- P040036THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER3PMA Approval
- P030031THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER3PMA Approval
- P950005CELSIUS FLTR UNI -DIRECTIONAL CATHETER3PMA Approval
- P030031THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER3PMA Approval
- P040036THERMOCOOK SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER3PMA Approval
- P110016FLEXABILITY ABLATION CATHETER (BI AND UNI DIRECTIONAL)3PMA Approval
- P040014THERAPY ABLATION CATHETER3PMA Approval
- P110016SAFIRE DUO AND COOL PATH DUO ABLATION CATHETERS3PMA Approval
- P060019THERAPY COOL PATH ABLATION CATHETER3PMA Approval
- P960016LIVEWIRE TC ABLATION CATHETER, SAFIRE ABLATION CATHETER3PMA Approval
- P110016FLEXABILITY ABLATION CATHETER3PMA Approval
- P990071SMARTABLATE SYSTEM3PMA Approval
- P990025CATHETER, PERCUTANEOUS, CARDIAC ABLATION NAVISTAR ELECTROPHYSIOLOGY CATHETER3PMA Approval
- P950005CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS ELECTROPHYSIOLOGY CATHETER,3PMA Approval
- P030031CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS THERMO-COOL ELECTROPHYSIOLOGY CATHETER3PMA Approval
- P920047BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II HTD TEMPERATURE ABLATION CATHETER3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER AND CABLE3PMA Approval
- P920047BLAZER II CARDIAC ABLATION CATHETER AND CABLE3PMA Approval
- P110016THERAPY COOL PATH DUO ABLATION CATHETER AND THERAPY COOL FLEX ABLATION CATHETER3PMA Approval
- P040014THERAPY ABLATION CATHETER INCLUDING BI-DIRECTIONAL CATHETER AND THERAPY 4MM THERNISTOR ABLATION CATHETER3PMA Approval
- P060019THERAPY COOL PATH ABLATION CATHETERS (INCLUDING ALL BRAID MODELS)3PMA Approval
- P920047BLAZER II, BLAZER II HTD, BLAZER PRIME HTD3PMA Approval
- P960016LIVEWIRE TC CARDIAC ABLATION SYSTEM3PMA Approval
- P020045CRYOCONSOLE3PMA Approval
- P930029RF CONTACTR,RF ENHANCR II,RF CONDUCTR,RF MARINR 5F,RF MARINR 7FR3PMA Approval
- P980003CHILLI II COOLED CATHETER ABLATION SYSTEM3PMA Approval
- P920047BLAZER II/ II HTD, BLAZER PRIME HTD SYSTEM CABLES3PMA Approval
- P110016THERAPY COOL PATH DUO CATHETER3PMA Approval
- P960016LIVEWIRE TC ABLATION CATHETER3PMA Approval
- P040014THERAPY CATHETER3PMA Approval
- P060019THERAPY COOL PATH CATHETER3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETERS3PMA Approval
- P920047BLAZER II, BLAZER II HTD AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS3PMA Approval
- P020045CRYOCONSOLE3PMA Approval
- P930029ATAKR RADIO FREQUENCY (RF) CATHETER ABLATION SYSTEM3PMA Approval
- P960016LIVEWIRE TC CARDIAC ABLATION SYSTEM3PMA Approval
- P020045FREEZOR CARDIAC CRYO-ABLATION CATHETER FAMILIES AND THE ARTIC FRONT3PMA Approval
- P920047BLAZER II /BLAZER II HTD,BLAZER PRIME (XP/HTD) ABLATION CATHETERS, ELECTROPHYSIOLOGY CABLES3PMA Approval
- P980003CHILLI II COOLED ABLATION SYSTEM3PMA Approval
- P040036EZ STEER THERMOCOOL NAV3PMA Approval
- P990025EZ STEER NAV3PMA Approval
- P030031EZ STEER THERMOCOOL NAV, THERMOCOOL SF NAV3PMA Approval
- P030031EZ STEER AND THERMOCOOL CATHETER FAMILIES3PMA Approval
- P990025EZ STEER NAV BI-DIRECTIONAL CATHETER AND NAVISTAR CATHETER3PMA Approval
- P950005EZ STEER DS BI-DIRECTIONAL CATHETER, CELSIUS CATHETER3PMA Approval
- P040036THERMOCOOL SMART TOUCH BI-DIRECTIONAL CATHETERS3PMA Approval
- P030031THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATIONAL CATHETER3PMA Approval
- P040036THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATIONAL CATHETER3PMA Approval
- P930029ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEMS.3PMA Approval
- P930029RF CONTACTR3PMA Approval
- P110016FLEXABILITY ABLATION CATHETER3PMA Approval
- P930029ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEMS.3PMA Approval
- P960016LIVEWIRE TC ABLATION CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER3PMA Approval
- P960016LIVEWIRE TC ABLATION CATHETERS3PMA Approval
- P920047MAESTRO 4000 CARDIAC ABLATION SYSTEM3PMA Approval
- P980003MAESTRO 4000 CARDIAC ABLATION SYSTEM3PMA Approval
- P980003CHILLI II COOLED ABLATION SYSTEM3PMA Approval
- P920047BLAZER II, BLAZER II HTD TEMPERATURE ABLATION CATHETERS3PMA Approval
- P990071SMARTABLATE SYSTEM3PMA Approval
- P030031NAVISTAR THERMOCOOL ELECTROPHYSIOLOGY CATHETER, CELSIUS THERMOCOOL ELECTROPHYSIOLOGY CATHETER3PMA Approval
- P950005CELSIUS ELECTROPHYSIOLOGY CATHETER3PMA Approval
- P990025NAVISTAR ELECTROPHYSIOLOGY CATHETER3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER3PMA Approval
- P920047BLAZER II CARDIAC ABLATION CATHETER3PMA Approval
- P040036THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER3PMA Approval
- P030031THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER3PMA Approval
- P990071COOLFLOW IRRIGATION PUMP3PMA Approval
- P950005CELSIUS FLUTTERS, CELSIUS, CELSIUS RMT, EZ STEER 4MM NON-NAV, EZ STEER DS, CELSIUS FLUTTERS3PMA Approval
- P990025NAVISTAR 4MM, NAVISTAR RMT 4MM, EZ STEER 4MM NAV3PMA Approval
- P030031NAVISTAR THERMOCOOL, CELSIUS THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL,CELSIUS RMT THERMOCOOL, THERMOCOOL3PMA Approval
- P040036NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, THERMOCOOL ST3PMA Approval
- P060019THE COOL POINT IRRIGATION PUMP3PMA Approval
- P960016LIVEWIRE TC AND SAFIRE BIDIRECTIONAL ABLATION CATHETER3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER3PMA Approval
- P0200457F FREEZOR CARDIAC CRYOABLATION CATH.& XTRA SURGICAL DEVICE, 9F FREEZOR MAX SURGICAL CATH CATHRYOCONSOLE SYSTEM3PMA Approval
- P920047BLAZER II, BLAZER II HTD, BLAZER PRIME HTD3PMA Approval
- P950005CELSIUS ELECTROPHYSIOLOGY CATHETER3PMA Approval
- P990025NAVI-STAR RMT ELECTROPHYSIOLOGY CATHETER3PMA Approval
- P920047BLAZER II TEMPERATURE ABLATION CATHETERS AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS USED WITH MAESTRO 3000 CARI3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER3PMA Approval
- P030031THERMO-COOL SF (BI-DIRECTIONAL AND UNI-DIRECTIONAL ) CATHETERS3PMA Approval
- P020045FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICES, FREEZOR MAX SURGICAL CRYOABLATION DEVICES,3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC C3PMA Approval
- P020045CRYOCONSOLE3PMA Approval
- P020045FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICES, FREEZOR MAX SURGICAL CRYOABLATION DEVICES3PMA Approval
- P930029RF CONTACTR, RF ENHANCR II, RF MARINR, RF MARINR UNIPOLAR, RF CONDUCTR CATHETERS3PMA Approval
- P040036THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER3PMA Approval
- P030031THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER3PMA Approval
- P950005CELSIUS FLTR UNI-DIRECTIONAL CATHETER3PMA Approval
- P930029RF ENHANCR II, RF MARINR 7FR, RF MARINR 5FR, RF MARINR UNIPOLAR, RF CONTACTR, RF CONDUCTR3PMA Approval
- P960016LIVEWIRE TC AND SAFIRE ABLATION CATHETERS3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETER, XTRA SURGICAL CRYOABLATION CATHETER, MAX SURGICAL CARDIAC CRYOABLATION CATHETER3PMA Approval
- P960016LIVEWIRE TC CARDIAC ABLATION SYSTEM CATHETER3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CARDIAC C3PMA Approval
- P040036NAVISTAR THERMOCOOL3PMA Approval
- P0200457F FREEZOR CARDIAC CRYOABLATION CATHETER & XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, 9F FREEZOR MAX SURGICAL CARDIAC3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETER; FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE3PMA Approval
- P020045FOCAL CATHETERS3PMA Approval
- P990071SMARTABLATE SYSTEM (FORMERLY STOCKERT 70 SYSTEM FOR CARDIAC ABLATION)3PMA Approval
- P950005CELSIUS CATHETER, CELSIUS RMT CATHETER3PMA Approval
- P030031NAVISTAR RMT THERMOCOOL, D-1266-XX, CELSIUS RMT THERMOCOOL D-1302 XX3PMA Approval
- P040036NAVISTAR RMT THERMOCOOL CATHETER3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER3PMA Approval
- P000020BARD ABLATION SYSTEM3PMA Approval
- P920047BLAZER II, BLAZER II HTD, BLAZER PRIME HTD3PMA Approval
- P930029RF MARINR MC/SC /SCXL/ SCXS/SCXXL/, RF CONTACTR, RF CONDUCTR & RF CONDUCTR II CARDIAC ABLATION CATHETERS.3PMA Approval
- P000020BARD ABLATION SYSTEM3PMA Approval
- P020045CRYOCONSOLE3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER AND CABLE3PMA Approval
- P920047BLAZER II CARDIAC ABLATION CATHETER AND CABLE3PMA Approval
- P110016THERAPY COOL PATH DUO CATHETER (12 HOLE IRRIGATED), SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED), COOL PATH DUO ABLATION C3PMA Approval
- P060019THERAPY COOL PATH CATHETER(6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6HOLE IRRIGATED) SAFIRE BLUE SP AND THERAPY3PMA Approval
- P960016LIVEWIRE TC ABLATION CATHETER (NON-IRRIGATED),SAFIRE ABLATION CATHETER (NON-IRRIGATED)3PMA Approval
- P040014THERAPY CATHETER (NON-IRRIGATED)3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER AND CABLE3PMA Approval
- P920047BLAZER II CARDIAC ABLATION CATHETER AND CABLE3PMA Approval
- P920047BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER AND CABLE3PMA Approval
- P920047BLAZER II CARDIAC ABLATION CATHETER AND CABLE3PMA Approval
- P960016LIVEWIRE TC ABLATION CATHETER (NON-IRRIGATED),SAFIRE ABLATION CATHETER (NON-IRRIGATED)3PMA Approval
- P040014THERAPY CATHETER (NON-IRRIGATED)3PMA Approval
- P060019THERAPY COOL PATH CATHETER (6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6 HOLE IRRIGATED), SAFIRE BLU SP3PMA Approval
- P110016THERAPY COOL PATH DUO CATHETER(12 HOLE IRRIGATED),SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED),COOL PATH DUO ABLATION3PMA Approval
- P930029RF CONDUCTR MC,RF CONTACTR,RF ENHANCR II,RF MARINR3PMA Approval
- P930029RF CONTACTR CATHETER, RF ENHANCR II CATHETER, RF MARINR CATHETER, RF CONDUCTR CATHETER3PMA Approval
- P960016LIVEWIRE TC CARDIAC ABLATION SYSTEM3PMA Approval
- P020045CRYOABLATION CONSOLE3PMA Approval
- P980003CHILLI COOLED ABLATION CATHETER AND CABLE3PMA Approval
- P920047BLAZER II CARDIAC ABLATION CATHETER AND CABLE3PMA Approval
- P040036THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM3PMA Approval
- P030031THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETER, ETRA SURGICAL CARDIAC CRYOABLATION DEVICE, MAX SURGICAL CARDIAC CRYOABLATION DEVI3PMA Approval
- P020045FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CRYOABLATION DEVICE3PMA Approval
- P950005CELSIUS CATHETER,CELSIUS RMT CATHETER,EZ STEER CATHETER,EZ STEER DS CATHETER, DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS,3PMA Approval
- P990071BIOSENSE WEBSTER CABLES3PMA Approval
- P990025NAVISTAR ,NAVISTAR RMT ,EZ STEER NAV CATHETERS AND,BIOSENSE WEBSTER CABLES3PMA Approval
- P040036NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL CATHETER,EZ STEER THERMOCOOL CATHETER,EZ STEER THERMOCOOL NAV CATH3PMA Approval
- P030031CELCIUS/ RMT THERMOCOOL ,NAVISTAR THERMOCOOL ,NAVISTAR RMT THERMOCOOL, THERMOCOOL, EZ STEER THERMOCOOL SF CATHETERS3PMA Approval
- P930029RF MARINR MC (7FR), RF MARINR 5FR, RF CONTACTR, RF CONDUCTR, RF ENHANCR II,3PMA Approval
- P920047BLAZER II, BLAZER II HTD,BLAZER PRIME HTD3PMA Approval
- P920047MAESTRO 3000 CARDIAC ABLATION SYSTEM3PMA Approval
- P980003MAESTRO 3000 CARDIAC ABLATION SYSTEM3PMA Approval
- P950005BIOSENSE WEBSTER CELSIUS FLTR CATHETER3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER3PMA Approval
- P920047BLAZER II/ BLAZER PRIME HTD ABLATION CATHETERS3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER AND CABLE3PMA Approval
- P920047BLAZER II CARDIAC ABLATION CATHETER AND CABLE3PMA Approval
- P040036THERMOCOOL SF3PMA Approval
- P950005NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, CELSIUS RMT THERMOCOOL3PMA Approval
- P030031EZ STEER3PMA Approval
- P980003CHILLI COOLED ABLATION SYSTEM3PMA Approval
- P920047EPT-1000 CARDIAC ABLATION SYSTEM3PMA Approval
- P040014THERAPY ABLATION CATHETERS3PMA Approval
- P920047BLAZER,BLAZER II HTD, AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER3PMA Approval
- P020045FREEZOR CARDIAC ABLATION CATHETER3PMA Approval
- P990025NAVISTAR RMT CATHETER,EZ STEER NAV CATHETER,BIOSENSE WEBSTER CABLES3PMA Approval
- P030031CELCIUS THERMOCOOL CATHETER,CELCIUS RMT THERMOCOOL CATHETER,NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL CATHETE3PMA Approval
- P040036NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL CATHETER,EZ STEER THERMOCOOL CATHETER,EZ STEER THERMOCOOL NAV CATHE3PMA Approval
- P950005CELSIUS CATHETER,CELSIUS RMT CATHETER,EZ STEER CATHETER,,EZ STEER DS CATHETER3PMA Approval
- P990071BIOSENSE WEBSTER CABLES3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER3PMA Approval
- P980003CHILLI II COOL ABLATION CATHETER3PMA Approval
- P040036EZ STEER THERMOCOOL NAV3PMA Approval
- P030031NAVISTAR THERMOCOOL3PMA Approval
- P960016LIVEWIRE TC ABLATION CATHETER3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION SYSTEM3PMA Approval
- P920047BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATI3PMA Approval
- P990025NAVISTAR CATHETER, NAVISTAR RMT CATHETER, EZ STEER NAY CATHETER, BIOSENSE WEBSTER CABLES3PMA Approval
- P040036NAVISTAR THERMOCOOL CATHETER, NAVISTAR RMT THERMOCOOL CATHETER, EZ STEER3PMA Approval
- P030031CELSIUS THERMOCOOL CATHETER, CELSIUS RMT THERMOCOOL CATHETER, CELSIUS RMT THERMOCOOL3PMA Approval
- P950005CELSIUS CATHETER, CELSIUS RMT CATHETER, EZ STEER DS CATHETER, DEFLECTABLE DIAGNOSTIC/ABLATION3PMA Approval
- P960016LIVEWARE TC ABLATION CATHETER3PMA Approval
- P990071SMARTABLATE SYSTEM-SMARTABLATE IRRIGATION PUMP KIT3PMA Approval
- P020045FREEZOR, FREEZOR XTRA AND FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE3PMA Approval
- P020045FREEZOR CARDIAC CRYO ABLATION CATHETER, FREEZOR XTRA SURGICAL CARDIAC CRYO ABLATION DEVICE, FREEZOR MAX SURGICAL CARDI3PMA Approval
- P950005BI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1359-XX-S)3PMA Approval
- P0400367.5 FR NAVI-STAR THERMO-COOL VATHETER WITH THERMISTOR3PMA Approval
- P0300317F CELCIUS THERMO-COOL CATHETER WITH THERMOCOUPLEM, 7F CELCIUS THERMOCOOL CATHETER WITH THERMMISTOR3PMA Approval
- P9900257F EZ STEER DS BI-DIRECTIONAL NAV CATHETER 4MM TIP ELECTRODE AND THERMOCOUPLE3PMA Approval
- P950005EZ STEER BI-DIRECTIONAL NON NAV 4 MM TIP WITH THERMOCOUPLE, 7F EZ NON-NAV CATHETER W/4MM TIP ELECTRODE AND THERMISTOR3PMA Approval
- P040036NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL,EZ STEER THERMOCOOL CATHETER,EZ STEER THERMOCOOL NAV CATHETER3PMA Approval
- P950005CELCIUS CATHETER,CELCIUS RMT CATHETER,EZ STEER CATHETER,EZ STEER DS CATHETER,DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERS,B3PMA Approval
- P030031CELCIUS THERMOCOOL CATHETER, CELCIUS RMT THERMOCOOL CATHETER,NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCOOL3PMA Approval
- P990071BIOSENSE WEBSTER CABLES3PMA Approval
- P990025NAVISTAR CATHETER,NAVISTAR RMT CATHETER,EZ STEER NAV CATHETER,BIOSENSE WEBSTER CABLES3PMA Approval
- P920047EPT-1000 CARDIAC ABLATION SYSTEM3PMA Approval
- P950005CELSIUS, CELSIUS RMT, EZ STEER, EZ STEER DS CATHETERS3PMA Approval
- P990071THERMOCOOL SF CATHETERS3PMA Approval
- P030031CELSIUS THERMOCOOL, CELSIUS RMT THERMOCOOL, NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL CATHETERS3PMA Approval
- P040036NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, EZ STEER THERMOCOOL NAV CATHETERS3PMA Approval
- P990025NAVISTAR, NAVISTAR RMT, EZ STEER NAV CATHETERS3PMA Approval
- P930029RF CONDUCTR 5 MM (7FR, 8FR TIP), RF CONDUCTR 4 MM (7FR), RF CONTACTR 5 MM (7FR, 8FR TIP), RF CONTACTR 5 MM (7FR, 8FR TIP3PMA Approval
- P920047BLAZER PRIME HTD3PMA Approval
- P990071STOCKERT 70 RADIOFREQUENCY GENERATOR3PMA Approval
- P950005CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER3PMA Approval
- P990025NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER3PMA Approval
- P030031NAVISTAR® THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER AND CELSIUS® THERMOCOOL® DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER3PMA Approval
- P040036NAVISTAR®THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER3PMA Approval
- P920047EPT-1000 CARDIAC ABLATION SYSTEM3PMA Approval
- P960016LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER (EPTC) EXT CBL, SAFIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, EXT CBL, S3PMA Approval
- P920047BLAZER II AND BLAZER PRIME HTD CARDIAC ABLATION CATHETERS3PMA Approval
- P930029RF ENCHANCER II ABLATION CATHETER3PMA Approval
- P930029RF CONDUCTR, RF CONTACTR, RF ENHANCER II, RF MARINR, RF MARINR UNIPOLAR3PMA Approval
- P980003CHILLI II COOL ABLATION CATHETER3PMA Approval
- P990071STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION3PMA Approval
- P000020BARD ABLATION SYSTEM3PMA Approval
- P990071STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION3PMA Approval
- P030031CELSIUS THERMOCOOL CATHETERS3PMA Approval
- P990025NAVI-STAR CATHETERS3PMA Approval
- P950005CELSIUS CATHETERS3PMA Approval
- P920047BLAZER PRIME HTD TEMPERATURE ABLATION CATHETER3PMA Approval
- P020045CRYOCONSOLE, MODEL 106A33PMA Approval
- P030031THERMOCOOL SF CATHETERS (BI-DIRECTIONAL), THERMOCOOL SF CATHETERS (UNI-DIRECTIONAL)3PMA Approval
- P960016SAFIRE ABLATION SYSTEM3PMA Approval
- P020045CRYOABLATION CONSOLE3PMA Approval
- P040014THERAPY CARDIAC ABLATION SYSTEM3PMA Approval
- P990071STOCKERT RADIOFREQUENCY GENERATOR3PMA Approval
- P950005CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER3PMA Approval
- P990025NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER3PMA Approval
- P030031CELSIUS THERMOCOOL CATHETER3PMA Approval
- P000020STINGER, STINGER S, STINGER M, STINGER SM, SCORPION 2, SCORPION 2M ABLATION CATHETERS3PMA Approval
- P030031THERMOCOOL SF BI-DIRECTIONAL AND UNI-DIRECTIONAL CATHETERS3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES3PMA Approval
- P920047BLAZER II CARDIAC ABLATION CATHETER AND CABLE3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER AND CABLE3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER AND CABLE3PMA Approval
- P920047BLAZER II CARDIAC ABLATION CATHETER AND CABLE3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES3PMA Approval
- P040036EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELECTROPHYSIOLOGY CATHETER3PMA Approval
- P030031EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELECTROPHYSIOLOGY CATHETER & THERMOCOOL SF NAV CATHETER3PMA Approval
- P990025EZ STEER NAV ELECTROPHYSIOLOGY CATHETER3PMA Approval
- P930029ATAKR RFCA SYSTEM3PMA Approval
- P980003CHILLI II COOLED ABLATION SYSTEM & STERILE CABLES3PMA Approval
- P920047BLAZER II, BLAZER II HTD CARDIAC ABLATION CATHETERS & BLAZER PRIME HTD CARDIAC ABLATION CATHETER & STERILE CABLES3PMA Approval
- P980003CHILLI COOLED ABLATION SYSTEM FOR THE CIRCUCOOL PUMP3PMA Approval
- P950005CELSIUS/CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE 4MM TIP CATHETERS/CELSIUS RMT DIAGNOSTIC/ABLATION STEERABLE TIP3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & MAX SURGICAL CARDIAC CRYOABLATION DEVICE3PMA Approval
- P030031NAVISTAR RMT THERMOCOOL CATHETER3PMA Approval
- P040036NAVISTAR RMT THERMOCOOL CATHETER3PMA Approval
- P930029RF CONTRACTR/RF CONDUCTR/RF MARINR/RF MARINR 5FR/RF ENHANCER II FAMILIES OF ABLATION CATHETERS3PMA Approval
- P040036CELSIUS RMT THERMOCOOL MAGNETIC CATHETER3PMA Approval
- P950005CELSIUS/CELSIUS RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION CATHETERS/INTERFACE CABLES3PMA Approval
- P030031NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETERS3PMA Approval
- P960016LIVEWIRE TC AND SAFIRE ABLATION CATHETERS3PMA Approval
- P040036CELSIUS RMT THERMOCOOL MAGNETIC CATHETER3PMA Approval
- P030031NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETERS3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER & CABLE3PMA Approval
- P920047BLAZER II CARDIAC ABLATION CATHETER & CABLE3PMA Approval
- P980003CHILLI II COOLED ABLATION SYSTEM & STERILE CABLES3PMA Approval
- P920047BLAZER II, BLAZER II HTD CARDIAC ABLATION CATHETERS & BLAZER PRIME HTD CARDIAC ABLATION CATHETER & STERILE CABLES3PMA Approval
- P930029RF CONTACTR, RF CONDUCTR, RF MARINR, RF MARINR 5FR AND RF ENHANCER II FAMILIES OF ABLATION CATHETERS3PMA Approval
- P040014THERAPY CARDIAC ABLATION SYSTEM3PMA Approval
- P980003CHILLI COOLED ABLATION SYSTEM3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & MAX SURGICAL CARDIAC CRYOABLATION DEVICE3PMA Approval
- P950005CELSIUS/CELSIUS RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION CATHETERS/INTERFACE CABLES3PMA Approval
- P040036NAVISTAR/NAVISTAR RMT THERMOCOOL/EZ STEER THERMOCOOL/EZ STEER THERMOCOOL NAV CATHETERS3PMA Approval
- P990071INTERFACE CABLES3PMA Approval
- P030031CELSIUS THERMOCOOL/CELSIUS RMT THERMOCOOL/NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/EZ STEER THERMOCOOL/NAV CATHETERS3PMA Approval
- P990025NAVISTAR/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR CATHETERS/INTERFACE CABLES3PMA Approval
- P030031NAVISTAR THERMOCOOL CATHETER FOR RADIOFREQUENCY ABLATION3PMA Approval
- P020045FREEZOR/FREEZOR XTRA/FREEZOR MAX CRYOABLATION CATHETERS AND THE CRYOCONSOLE3PMA Approval
- P930029RF CONDUCTR MC/RF CONTACTR/RF ENHANCR II/RF MARINR MC 7F/SC 5F/RF MARNIR UNIPOLAR/RF CONDUCTR MC ABLATION CATHETERS3PMA Approval
- P920047BLAZER PRIME HTD CARDIAC ABLATION CATHETER3PMA Approval
- P930029RF CONDUCTR MC/RF CONTACTR/RF ENHANCR II/RF MARINR MC 7F/SC 5F/RF MARNIR UNIPOLAR/RF CONDUCTR MC ABLATION CATHETERS3PMA Approval
- P960016LIVEWIRE TC CARDIAC ABLATION SYSTEM3PMA Approval
- P920047BLAZER II & BLAZER PRIME HTD CATHETERS3PMA Approval
- P980003CHILLI II CATHETERS3PMA Approval
- P980003CHILLI II CATHETER3PMA Approval
- P920047BLAZER II/PRIME HTD CATHETER3PMA Approval
- P020045CARDIAC ABLATION PERCUTANEOUS CATHETER3PMA Approval
- P930029RF CONDUCTR MC/RF CONTACTR/RF ENHANCR II/RF MARINR MC 7F/SC 5F/RF MARNIR UNIPOLAR/RF CONDUCTR MC ABLATION CATHETERS3PMA Approval
- P930029VARIOUS FAMILIES OF ELECTROPHYSIOLOGY SYSTEMS3PMA Approval
- P040014THERAPY CARDIAC ABLATION CATHETER3PMA Approval
- P930029CATH RF CONDUCTR/5 MM 8FR/RF MC 078 6022/CONTACTR CATHETER 7 FR 5MM/RF CONDUCTR MC SELF-REFERENCE CATHETER/RF ENHANCR II3PMA Approval
- P020045FREEZOR/FREEZOR XTRA/FREEZOR MAX CRYOABLATION CATHETERS AND THE CRYOCONSOLE3PMA Approval
- P020045UNIVERSAL CRYOCONSOLE3PMA Approval
- P980003CHILLI COOLED ABLATION SYSTEM3PMA Approval
- P950005CELSIUS/RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION/INTERFACE CABLES3PMA Approval
- P990025NAVISTAR/RMT/EZ STEER NAV/QWIKSTAR/INTERFACE CABLES3PMA Approval
- P990071INTERFACE CABLES3PMA Approval
- P040036NAVISTAR THERMOCOOL//NAVISTAR RMT//EZ STEER/EZ STEER THERMOCOOL NAV CATHETERS3PMA Approval
- P030031CELSIUS THERMOCOOL/RMT//NAVISTAR/NAVISTAR RMT/EZ STEER/EZ STEER THERMOCOOL NAV CATHETERS3PMA Approval
- P920047BLAZER II XP CARDIAC ABLATION CATHETER/CABLE/BLAZER II HIGH TORQUE DISTAL (HTD) ABLATION CATHETER/CABLE/BLAZER PRIME3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER & CABLE3PMA Approval
- P000020STINGER/STRINGER S/STINGER M/STINGER SM/SCORPION 2/SCORPION 2M ABLATION CATHETERS AND THE TEMPLINK/TEMPLINK M EXTENSION3PMA Approval
- P950005WEBSTER ELECTROPHYSIOLOGY CATHETER/CELSIUS ABLATION CATHETER3PMA Approval
- P990025NAVISTAR RMT CATHETER3PMA Approval
- P030031NAVISTAR THERMOCOOL CATHETER FAMILY3PMA Approval
- P040036NAVISTAR THERMOCOOL CATHETER FAMILY3PMA Approval
- P040014THERAPY/THERAPY BI-DIRECTIONAL/THERAPY 4MM THERMISTOR ABLATION CATHETERS3PMA Approval
- P950005CELSIUS RMT CATHETER (4MM)3PMA Approval
- P990025NAVISTAR RMT CATHETER (4MM)3PMA Approval
- P920047BLAZER II CARDIAC ABLATION CATHETERS3PMA Approval
- P980003CHILLI COOLED ABLATION SYSTEM3PMA Approval
- P040014THERAPY ABLATION CATHETER3PMA Approval
- P960016LIVEWIRE TC CARDIAC ABLATION SYSTEM3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES3PMA Approval
- P930029RF /RF MARINR NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II ABLATION/RF CONTACTR CATHETERS3PMA Approval
- P960016LIVEWIRE TC CARDIAC ABLATION SYSTEM3PMA Approval
- P960016LIVEWIRE CARDIAC ABLATION SYSTEM3PMA Approval
- P930029RF MARINR/NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II ABLATION/RF CONTACTR/CONDUCTR SELF-REF/ATAKR II3PMA Approval
- P980003MODEL 8005 CIRCUCOOL PUMP3PMA Approval
- P960016SAFIRE CARDIAC ABLATION SYSTEM3PMA Approval
- P930029RF MARINR/NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II/RF CONTACTR3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETERS/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES & CRYOCONSOLE SYSTEM3PMA Approval
- P950005CELSIUS CATHETER, NON-TEMPERATURE SENSING ABLATION CATHETERS, INTERFACE CABLES3PMA Approval
- P040036NAVISTAR THERMOCOOL3PMA Approval
- P990025NAVISTAR CATHETER, INTERFACE CABLES3PMA Approval
- P990071EZ STEER THERMOCOOL CATHETERS3PMA Approval
- P030031CELSIUS THERMOCOOL & NAVISTAR THERMOCOOL3PMA Approval
- P020045FREEZOR/FREEZOR XTRA SURGICAL/FREEZOR MAX SURGICAL CATHETERS AND CRYOCONSOLE3PMA Approval
- P960016LIVEWIRE TC CARDIAC ABLATION SYSTEM3PMA Approval
- P920047BLAZER II/BLAZER PRIME HTD ABLATION CATHETERS3PMA Approval
- P960016LIVEWIRE TC CARDIAC ABLATION SYSTEM3PMA Approval
- P930029RF MARINR/NTC/5RF MARINR/RF CONDUCTR/RF ENHANCR II/RF CONTACTR3PMA Approval
- P930029RF MARINR/RF MARINR NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II/ RF CONTACTR3PMA Approval
- P960016LIVEWIRE TC CARDIAC ABLATION SYSTEM3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETER/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES & CCT.2 CRYOCONSOLE3PMA Approval
- P030031CELSIUS THERMOCOOL CATHETER3PMA Approval
- P030031EZ STEER THERMOCOOL NAV CATHETER3PMA Approval
- P040036EZ STEER THERMOCOOL NAV CATHETER3PMA Approval
- P920047BLAZER PRIME HTD CATHETER3PMA Approval
- P040036CELSIUS RMT THERMOCOOL CATHETER3PMA Approval
- P030031NAVISTAR RMT THERMOCOOL CATHETER3PMA Approval
- P960016LIVEWIRE TC AND SAFIRE ABLATION CATHETERS3PMA Approval
- P030031NAVISTAR RMT THERMOCOOL CATHETER3PMA Approval
- P040036CELSIUS RMT THERMOCOOL CATHETER3PMA Approval
- P990071COOLFLOW TUBING IFU3PMA Approval
- P960016LIVEWIRE TC CARDIAC ABLATION SYSTEM3PMA Approval
- P040014THERAPY CARDIAC ABLATION CATHETER/THERAPY 4MM THERMISTOR/THERAPY BI-DIRECTIONAL CATHETERS3PMA Approval
- P030031CELSIUS THERMOCOOL & NAVISTAR THERMOCOOL3PMA Approval
- P990025NAVISTAR/EZ STEER NAV/QWIKSTAR3PMA Approval
- P950005CELSIUS/EZ STEER3PMA Approval
- P040036NAVISTAR THERMOCOOL3PMA Approval
- P030031NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/ EZ STEER THERMOCOOL NAV3PMA Approval
- P990025NAVISTAR/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR3PMA Approval
- P040036NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/ EZ STEER THERMOCOOL NAV3PMA Approval
- P920047BLAZER PRIME/BLAZER II/BLAZER XP/BLAZER HTD TEMPERATURE ABLATION CATHETERS3PMA Approval
- P980003CHILI/CHILI II COOLED ABLATION SYSTEM AND CATHETER3PMA Approval
- P000020STINGER/STRINGER S/STINGER M/STINGER SM/SCORPION/SCORPION M/SCORPION *2/SCORPION *2 M ABLATION CATHETERS3PMA Approval
- P040014THERAPY CARDIAC ABLATION CATHETER3PMA Approval
- P040036NAVISTAR (4MM, DS, THERMOCOOL AND RMT)3PMA Approval
- P990025NAVISTAR THERMOCOOL AND NAVISTAR RMT THERMOCOOL CATHETERS3PMA Approval
- P030031EZ STEER NAV AND EZ STEER NAV DS CATHETERS3PMA Approval
- P030031NAVISTAR RMT THERMOCOOL CATHETER3PMA Approval
- P960016SAFIRE CARDIAC ABLATION SYSTEM3PMA Approval
- P960016SAFIRE CARDIAC ABLATION SYSTEM3PMA Approval
- P990025NAVISTAR RMT3PMA Approval
- P950005CELSIUS RMT3PMA Approval
- P040036NAVISTAR RMT THERMOCOOL3PMA Approval
- P030031NAVISTAR RMT THERMOCOOL3PMA Approval
- P030031NAVISTAR AND CELSIUS THERMOCOOL CATHETERS3PMA Approval
- P960016SAFIRE CARDIAC ABLATION SYSTEM3PMA Approval
- P920047BLAZER PRIME HTD CARDIAC ABLATION CATHETERS3PMA Approval
- P960016LIVEWIRE TC & SAFIRE CARDIAC ABLATION SYSTEMS3PMA Approval
- P040014THERAPY CARDIAC ABLATION CATHETER3PMA Approval
- P030031NAVISTAR THERMOCOOL CATHETER3PMA Approval
- P950005CELSIUS RMT AND NAVISTAR RMT CATHETERS3PMA Approval
- P990025NAVISTAR RMT CATHETERS3PMA Approval
- P920047EP TECH CARDIAC ABLATION SYSTEM3PMA Approval
- P020025EP TECH EPT-1000XP RF ABLATION SYSTEM3PMA Approval
- P020045FREEZOR CARDIAC/FREEZOR XTRA/FREEZOR MAX SURGICAL CARDIAC CRYOABLATION CATHETER/CCT.2 CRYOCONSOLE SYSTEM3PMA Approval
- P040014THERAPY CARDIAC ABLATION CATHETERS3PMA Approval
- P930029RF CONDUCTR ABLATION CATHETERS3PMA Approval
- P040014THERAPY ABLATION CATHETERS3PMA Approval
- P990025CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATHETERS3PMA Approval
- P950005CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATHETERS3PMA Approval
- P000020STINGER, STINGER S, SCORPION, SCORPION *2 ABLATION CATHETERS AND TEMPLINK EXTENSION CABLES3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETERS/FREEZOR XTRA & FREEZOR MAX SURGICAL CRYOABLATION DEVICES& CCT.2 CRYOCONSOLE SYSTE3PMA Approval
- P040036NAVISTAR RMT THERMOCOOL DIAGNOSTIC / ABLATION STEERABLE TIP CATHETER3PMA Approval
- P030031NAVISTAR RMT THERMOCOOL DIAGNOSTIC / ABLATION STEERABLE TIP CATHETER3PMA Approval
- P040036NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC / ABLATION CATHETERS3PMA Approval
- P030031NAVISTAR THERMOCOOL & CELSIUS THERMOCOOL DIAGNOSTIC/ABLATION CATHETERS3PMA Approval
- P040014THERAPY CARDIAC ABLATION CATHETER3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETER/ FREEZOR XTRA & MAX SURGICAL CRYOABLATION & CCT.2 CRYOCONSOLE SYSTEM3PMA Approval
- P990025NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER3PMA Approval
- P030031NAVISTAR RMT CATHETER FAMILY3PMA Approval
- P040036NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER3PMA Approval
- P920047STEEROCATH T CARDIAC ABLATION CATHETER3PMA Approval
- P050029HELIOS II ABLATION CATHETER3PMA Approval
- P040036EZ STEER THERMOCOOL AND3PMA Approval
- P030031EZ STEER THERMOCOOL AND EZ STEER THERMOCOOL NAV DIAGNOSTIC/ABLATION CATHETERS3PMA Approval
- P980003CHILLI COOLED ABLATION CATHETER3PMA Approval
- P920047BLAZER II CARDIAC ABLATION CATHETERS3PMA Approval
- P980003CHILLI II COOLED ABLATION SYSTEM3PMA Approval
- P040014THERAPY CARDIAC ABLATION CATHETERS3PMA Approval
- P000020SCORPION & SCORPION M ABLATION CATHETERS3PMA Approval
- P960016LIVEWIRE TC CARDIAC ABLATION SYSTEM3PMA Approval
- P950005EZ STEER 8MM AND 4MM NON-NAVIGATIONAL BI-DIRECTIONAL CATHETERS3PMA Approval
- P990025EZ STEER 4MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS3PMA Approval
- P040036NAVISTAR RMT THERMOCOOL LINE EXTENSION3PMA Approval
- P030031NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS3PMA Approval
- P960016SAFIRE BIDIRECTIONAL ABLATION CATHETER3PMA Approval
- P950005CELSIUS RMT CATHETER3PMA Approval
- P030031NAVISTAR THERMOCOOL CATHETER FOR TREATMENT OF TYPE I ATRIAL FLUTTER3PMA Approval
- P030031NAVISTAR & CELSIUS CATHETERS3PMA Approval
- P040036NAVISTAR CATHETERS3PMA Approval
- P950005CELSIUS & EZ STEER FAMILIES OF CATHETERS3PMA Approval
- P990025QUIKSTAR FAMILY OF CATHETERS3PMA Approval
- P030031NAVISTAR & CELSIUS FAMILIES OF CATHETERS3PMA Approval
- P040036NAVISTAR FAMILY OF CATHETERS3PMA Approval
- P980003MODEL 8005 PUMP SYSTEM (CIRCUCOOL PUMP), MODEL M004800503PMA Approval
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- P990025NAVISTAR 4 MM BI DIRECTIONAL DIAGNOSTIC/ABLATION CATHETER3PMA Approval
- P950005CELSIUS,CELSIUS II, CELSIUS RMT, EZ STEER, EZ STEER DS DIAGNOSTIC/ABLATION CATHETERS3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER3PMA Approval
- P040014IBI THERAPY CARDIAC ABLATION SYSTEM ERS/1500T RF GENERATOR3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION CATHETERS & CCT. CRYOCONSOLE3PMA Approval
- P960016SAFIRE CARDIAC ABLATION SYSTEM3PMA Approval
- P040036NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER3PMA Approval
- P030031NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER3PMA Approval
- P020045FREEZOR,FREEZOR XTRA & FREEZOR MAX CRYOABLATION DEVICES3PMA Approval
- P040014IBI THERAPY CARDIAC ABLATION SYSTEM3PMA Approval
- P040014THERAPY ABLATION CATHETERS3PMA Approval
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- P990025NAVISTAR 4 MM BI-DIRECTIONAL DIAGNOSTIC/ABLATION CATHETERS3PMA Approval
- P950005EZ STEER AND EZ STEER DS BIDIRECTIONAL DIAGNOSTIC/ABLATION CATHETERS3PMA Approval
- P040036NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETERS; FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION CATHETERS3PMA Approval
- P020045CCT.2 CRYOABLATION CONSOLE SYSTEM3PMA Approval
- P920047BLAZER RF ABLATION CATHETER3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX CARDIAC CRYOABLATION CATHETERS3PMA Approval
- P980003CHILLI COOLED ABLATION SYSTEM3PMA Approval
- P990054CHILLI COOLED RPM CATHETER3PMA Approval
- P960016LIVEWIRE TC CARDIAC ABLATION SYSTEM3PMA Approval
- P990071STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION3PMA Approval
- P020045FREEZOR CARDIAC CRYOABLATION CATHETERS AND FREEZOR XTRA SURGICAL CRYOABLATION CATHETERS & CCT.2 CRYOCONSOLE SYSTEM3PMA Approval
- P020045CCT.2 CRYOABLATION CONSOLE SYSTEM3PMA Approval
- P990025QWIKSTAR NAVIGATION/ABLATION CATHETER3PMA Approval
- P960016LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER ? SAFIRE MODEL3PMA Approval
- P990025NAVISTAR DIAGNOSTIC ABLATION TIP CATHETER,QWIKSTAR DIAGNOSTIC ABLATION CATHETER3PMA Approval
- P950005NAVISTAR DIAGNOSTIC ABLATION TIP CATHETER, CELSIUS DIAGNOSTIC3PMA Approval
- P000020SCORPION/SCORPION M ABLATION CATHETER3PMA Approval
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- P040014IBI CARDIAC ABLATION SYSTEM3PMA Approval
- P920047EPT 1000TC AND EPT 1000XP CARDIAC ABLATION SYSTEM3PMA Approval
- P040014IBI THERAPY ABLATION CATHETERS3PMA Approval
- P0200457F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM3PMA Approval
- P0200457F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM3PMA Approval
- P920047MAESTRO 3000 CARDIAC ABLATION SYSTEM & CATHETERS3PMA Approval
- P980003MAESTRO 3000 CARDIAC ABLATION SYSTEM3PMA Approval
- P920047CARDIAC ABLATION CATHETERS3PMA Approval
- P0200457F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM3PMA Approval
- P990071STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION3PMA Approval
- P0200457F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM3PMA Approval
- P0200457F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM3PMA Approval
- P920047BLAZER II AND BLAZER II XP CARDIAC ABLATION CATHETERS3PMA Approval
- P000020STINGER, STINGER S, STINGER M, & STINGER SM ABLATION CATHETER3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER3PMA Approval
- P0200457F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER3PMA Approval
- P920047BLAZER II AND BLAZER II XP CARDIAC ABLATION CATHETERS3PMA Approval
- P040014IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR3PMA Approval
- P920047BLAZER II CARDIAC ABLATION CATHETERS3PMA Approval
- P0200459F FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE3PMA Approval
- P980003CHILLI II COOLED ABLATION CATHETER3PMA Approval
- P960016LIVEWIRE TC CARDIAC ABLATION SYSTEM3PMA Approval
- P960016LIVEWIRE TC CARDIAC ABLATION SYSTEM3PMA Approval
- P920047BLAZER II XP AND BLAZER XP RPM CATHETERS3PMA Approval
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- P930029MEDTRONIC MODEL 4819 ABLATION CATHETER TO EP RECORDING SYSTEM CABLE3PMA Approval
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- P990054CHILLI COOLED ABLATION SYSTEM3PMA Approval
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- P930029ATAKR(TM) RFCA SYSTEM3PMA Approval
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- P930029ATAKR RFCA SYSTEM3PMA Approval
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- LPCDevice, Angioplasty, Laser, Coronary3Product Code
- LWOPulse-Generator, Single Chamber, Sensor Driven, Implantable3Product Code
- LWPImplantable Pulse Generator, Pacemaker (Non-Crt)3Product Code
- LWQHeart-Valve, Mechanical3Product Code
- LWRHeart-Valve, Non-Allograft Tissue3Product Code
- LWSImplantable Cardioverter Defibrillator (Non-Crt)3Product Code
- LWTOccluder, Balloon, Vena-Cava3Product Code
- LWWPulse-Generator, Single Chamber, Single3Product Code
- LWXDevice. Laser Peripheral Angioplasty3Product Code
- LWZTissue Graft Of Less Than 6mm3Product Code
- LXATissue Graft Of 6mm And Greater3Product Code
- MADCatheter, Percutaneous (Valvuloplasty)3Product Code
- MAEOccluder, Patent Ductus, Arteriosus3Product Code
- MAFStent, Coronary3Product Code
- MCXCatheter, Coronary, Atherectomy3Product Code
- MFADevice, Removal, Pacemaker Electrode, Percutaneous3Product Code
- MGBDevice, Hemostasis, Vascular3Product Code
- MIEHeart-Valve, Allograft3Product Code
- MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment3Product Code
- MIRShunt, Portosystemic, Endoprosthesis3Product Code
- MLVTranscatheter Septal Occluder3Product Code
- MNOSystem, Laser, Transmyocardial Revascularization3Product Code
- MOMSystem, Hemodynamic, Implantable3Product Code
- MOUIntravascular Radiation Delivery System3Product Code
- MRMDefibrillator, Implantable, Dual-Chamber3Product Code
- MTESystem, Pacing, Temporary, Acute, Internal Atrial Defibrillation3Product Code
- MUQGlue, Surgical, Arteries3Product Code
- MVKWearable Automated External Defibrillator3Product Code
- MWGSystem, Oxygen, Aqueous3Product Code
- MWHPulmonic Valved ConduitFProduct Code
- NAPCardiac Support Mesh WrapNProduct Code
- NAVGraft, Bypass, Coronary ArteryFProduct Code
- NGVSystem, Appendage Closure, Left Atrial3Product Code
- NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)3Product Code
- NIMStent, Carotid3Product Code
- NINStent, Renal3Product Code
- NIOStent, Iliac3Product Code
- NIPStent, Superficial Femoral Artery3Product Code
- NIQCoronary Drug-Eluting Stent3Product Code
- NIUStent, Superficial Femoral Artery, Drug-Eluting3Product Code
- NIVCoronary Covered StentFProduct Code
- NKEPulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)3Product Code
- NKMMitral Valve Repair Devices3Product Code
- NPTAortic Valve, Prosthesis, Percutaneously Delivered3Product Code
- NPUProsthesis, Mitral Valve, Percutaneously Delivered3Product Code
- NPVPulmonary Valve Prosthesis Percutaneously DeliveredFProduct Code
- NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes3Product Code
- NVYPermanent Defibrillator Electrodes3Product Code
- NVZPulse Generator, Permanent, Implantable3Product Code
- NWXCatheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring3Product Code
- OADCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter3Product Code
- OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation3Product Code
- OBCOccluder, Internal Vessel, Temporary3Product Code
- OBDBarrier, Adhesion, Cardiovascular3Product Code
- OCMSurgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation3Product Code
- ODTTissue Adhesive, Aortic AneurysmorrhaphyFProduct Code
- OHAHeart Valve, More Than Minimally Manipulated AllograftUProduct Code
- OJERight Ventricular Bypass (Assist) DeviceFProduct Code
- OJXDrug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode3Product Code
- ONUDrug-Eluting Peripheral Transluminal Angioplasty Catheter3Product Code
- OSRPacemaker/Icd/Crt Non-Implanted Components3Product Code
- OZDTemporary Non-Roller Type Left Heart Support Blood Pump3Product Code
- OZGTranscatheter Septal Occluder (Atrial)3Product Code
- OZHTranscatheter Septal Occluder (Ventricular)3Product Code
- PAPAortic Heart Valve, More Than Minimally Manipulated AllograftFProduct Code
- PCWImplantable Pulse Generator, Programmer And Battery ChargerNProduct Code
- PCXArtificial Chordae Tendinae Delivery SystemNProduct Code
- PFVSystem, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment3Product Code
- PIZCombination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve3Product Code
- PJQAgent, Occluding, Vascular, Permanent3Product Code
- PKKStent Delivery SystemNProduct Code
- PNFAortic Stent3Product Code
- PNYAbsorbable Coronary Drug-Eluting Stent3Product Code
- PRCDrug-Coated Peripheral Transluminal Angioplasty Catheter3Product Code
- PRLIliac Covered Stent, Arterial3Product Code
- QANStent, Iliac Vein3Product Code
- QBIAcute Coronary Syndrome Event Detector3Product Code
- QCTScaffold, Dissection Repair3Product Code
- QFVImplantable Pulse Generator3Product Code
- QLJPatient Monitor With Independent Remote Display And OperationNProduct Code
- QLLLeft Ventricular Ejection Fraction Screening ToolNProduct Code
- QLMIntensive Care Unit, Respiratory Failure And Hemodynamic Instability ToolNProduct Code
- QLNExtracorporeal System For Carbon Dioxide Removal For The Treatment Of Covid-19NProduct Code
- QMGShockwave Intravascular Lithotripsy System3Product Code
- QNYRemote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation MonitoringNProduct Code
- QNZPowered Communication System For Emergency UseNProduct Code
- QOAPpg Sensor Wearable For Hypercoagulation Detection And Covid-19 ScreeningNProduct Code
- QOCTemporary Non-Roller Type Left Or Right Heart Support Blood PumpNProduct Code
- QIKOrgan Care System (Ocs) Heart System3Product Code
- QSKHybrid Stent Graft, Thoracic Aortic Lesion Treatment3Product Code
- QWACardiovascular Delivery Catheter System Positioning And Stabilization Device1Product Code
- QWMStent Graft, Bypass, Superficial Femoral Artery3Product Code
- QXOCardiovascular Machine Learning-Based Notification Software2Product Code
- QWCPulmonary Stent3Product Code
- QVQExtravascular Support For An Arteriovenous Fistula For Vascular Access3Product Code
- QXVTemperature Regulation Device For Esophageal Protection During Cardiac Ablation2Product Code
- QWNStent Graft, Infrapopliteal, Venous Arterialization3Product Code
- QXUEsophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation2Product Code
- QXXCoronary Artery Disease Machine Learning-Based Notification Software2Product Code
- QYEReduced Ejection Fraction Machine Learning-Based Notification Software2Product Code
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- QZIPercutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation3Product Code
- QZKEndovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions3Product Code
- QZUTemporary Embolization Assist Device, Peripheral2Product Code
- NPWPercutaneously Delivered Prostheses And Tricuspid Valves3Product Code
- OOBDrug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter3Product Code
- NPSTricuspid Valve Repair Device, Percutaneously Delivered3Product Code
- SATPulmonary Hypertension Machine Learning-Based Notification Software2Product Code
- SBKArtificial Chordae Tendineae Surgical Replacement System2Product Code
- SBQAtrial Fibrillation Risk Prediction Machine Learning-Based Notification Software2Product Code
- QXYOscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification2Product Code
- SCZPercutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures2Product Code
- NXWScaffold, Infrapopliteal, Absorbable3Product Code
- SEGLeadless Cardiac Resynchronization Therapy (Crt)3Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER; THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAVIGATION CATHETE
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- BIOSENSE WEBSTER, INC.
- Trade Name
- BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS
- Generic Name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision Date
- 11/5/2004
- Days to Decision
- 466 days
- Decision Code
- APPR
- FDA Decision
- Approval