Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion Sysstem, Ascenda Intrathecal Catheters

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

FDA Pre-Market Approval

FDA Class 3 ·IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·Cool Point Tubing Set

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

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

FDA Pre-Market Approval

FDA Class 3 ·COOL POINT(TM) TUBING SET

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare HVAD System

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED RF ABLATION SYSTEM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D/ Quad CRT_D; Brava CRT-D/ Quad CRT-D; Claria MRI CRT-D / Quad CRT-D; Compia MRI Quad CRT-D; Viva Quad X

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF ICD /MRI ICD / S DR / S VR / XT DR /XT VR ICD's; Visia AF MRI DFI ICD / AF MRI VR ICD / AF VR ICD.

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THE COOL POINT IRRIGATION PUMP

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartStart FR3 Primary Battery (989803150161)

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·PROPEL SINUS IMPLANT & PROPEL MINI SINUS IMPLANT

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH ABLATION CATHETER AND IBI-1500T9 RF ABLATION GENERATOR