Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Bowel Screening)

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT DS ,EZ STEER NAV DS ,CELSIUS FLTR, CELSIUS DS, & NAVISTAR DS CATHETERS

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 ABLATION CATHETERS

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

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·Celsius FLTR (Flutter) Catheter, EZ STEER NAV Bi-Directional and EZ STEER NAV DS Bi-Directional Diagnostic/Ablation Defl

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

FDA Pre-Market Approval

FDA Class 3 ·Ampere™ Generator, Ampere™ Remote Control, Ampere™ Generator System Kit

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR DS Electrophysiology Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·NaviStar THERMOCOOL Deflectable Diagnostic/Ablation Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·Artic Front Advance Cardiac Cryoablation Catheter, 23/28mm, US

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer OI and IntellaNav OI

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

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS RMT, NAVISTAR RMT AND NAVISTAR RMT DS CATHETERS

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

FDA Pre-Market Approval

FDA Class 3 ·ThermoCool SmartTouch

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

FDA Pre-Market Approval

FDA Class 3 ·FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enable (Flex SE)

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer II XP Cardiac Ablation Catheter and Cable

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

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL & UNI-DIRECTIONAL NAVIGATION CATHETER

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ARCTIC FRONT CARDIAC CYROABLATION CATHETER, ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·Open-Irrigated Ablation Catheters: Blazer OI, IntellaTip MiFi OI, and IntellaNav OI