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

FDA Pre-Market Approval

FDA Class 3 ·8mm Dual Sensor (DS) Catheters

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·Therapy Cool Flex, Path Duo, Safire Duo, MediGuide Enabled Ablation Catheter; Mediguide Enabled

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

FDA Pre-Market Approval

FDA Class 3 ·TACTICATH QUARTZ ABLATION CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

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

FDA Pre-Market Approval

FDA Class 3 ·TactiCath Quartz Contact Force Ablation Catheter, TactiCath Contact Force Ablation Catheter, Sensor Enabled

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

FDA Pre-Market Approval

FDA Class 3 ·DiamondTemp Ablation System

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

FDA Pre-Market Approval

FDA Class 3 ·TactiCath Ablation Catheter, Sensor Enabled (SE)

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

FDA Pre-Market Approval

FDA Class 3 ·Navistar DS, Celsius DS, EZ Steer DS Bi-directional non nav, EZ Steer Nav DS Bi-directional, Celsius FLTR Uni-directiona

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Interm Therapy System, Verify Evaluation System (SNS Bowel)

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance Cardiac CryoAblation Catheters

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22 URINE COLLECTION KIT

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl

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 Flutter

FDA Pre-Market Approval

FDA Class 3 ·IntellaNav XP and IntellaNav MiFi XP ablation catheters

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)

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·EPi-Sense ST RF Cable