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

FDA Pre-Market Approval
FDA Class 3 ·EZ Steer NAV DS Bi-Directional Electrophysiology Catheter

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 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™)

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

FDA Pre-Market Approval
FDA Class 3 ·DiamondTemp Ablation Catheters

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

FDA Pre-Market Approval
FDA Class 3 ·TactiFlex Ablation Catheter SE (A-TFSE-D, A-TFSE-F, A-TFSE-J, A-TFSE-DD, A-TFSE-DF, A-TFSE-FF, A-TFSE-FJ, A-TFSE-JJ, A-T

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

FDA Pre-Market Approval
FDA Class 3 ·HeartLight Catheter, HeartLight X3 Console V2

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

FDA Pre-Market Approval
FDA Class 3 ·Blazer Open Irrigated Temperature 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

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 ·THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL PATH SP ABLATION CATHETER, SAFIRE BLU ABLATION CATHETER

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System (Bowel)

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

FDA Pre-Market Approval
FDA Class 3 ·DIAMOND AF

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

FDA Pre-Market Approval
FDA Class 3 ·TactiSys™ Quartz Equipment

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

FDA Pre-Market Approval
FDA Class 3 ·HeartLight Endoscopic Ablation System

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·Elecsys free PSA Immunoassay

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

FDA Pre-Market Approval
FDA Class 3 ·Arctic Front Cryocatheter System

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY

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

FDA Pre-Market Approval
FDA Class 3 ·FlexAbility Ablation Catheter, FlexAbility Ablation Catheter Sensor Enabled

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

FDA Pre-Market Approval
FDA Class 3 ·EPT-1000 XP CARDIAC ABLATION SYSTEM CONTROLLER AND ACCESSORIES AND MAESTRO 3000 CARDIAC ABLATION SYSTEM AND ACCESSORIES

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim Therapy System, Verify Evaluation System (SNS Bowel)