Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) LEGEND PLUS(TM) PULSE GENERATOR

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER THERMOCOOL CATH, EZ STEER THERMOCOOL NAV CATH NAVISTAR RMT THERMOCOOL & THERMOCOOL CATH, THERMOCOOL SMARTTOUCH

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS RMT THERMOCCOL CAT, CELSIUS THERMOCCOL CATH NAVISTAR & RMT THERMOCOOL CATHS,THERMOCOOL SF, SMARTTOUCH& NAV CATH

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Celsius DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, EZ Steer Nav DS Catheter, Interface Cables

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer Navigational 4mm; C3 EZ Steer Thermocool Nav; Ez Steer Thermocool Non-Navigational 4mm (TC); EZ Steer Thermocoo

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, and Biosens

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval

FDA Class 3 ·AAV5 DetectCDx®

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval

FDA Class 3 ·AAV5 DetectCDx

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D-1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·BIOSENSE WEBSTER CABLES, CELSIUS DS CATHETER, CELSIUS FLTR, EZ STEER NAV DS CATH, NAVISTAR DS CATH, NAVISTAR RMT DS CATH

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS FLTR BI-DIRECTIONAL CATHETER

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance and Arctic Front Advance Pro