Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·NEOMEND PROGEL PLEURAL AIR LEAK SEALANT

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·HERCULINK ELITE RX STENT SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOK SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER

Scaffold, Infrapopliteal, Absorbable

FDA Pre-Market Approval

FDA Class 3 ·Esprit™ BTK Everolimus Eluting Resorbable Scaffold System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Spinal Cord Stimulation (SCS)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS THERMOCOOL, CELSIUS RMT THERMOCOOL, NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT THERMOCOOL CATHETER

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·CONTINUOUS GLUCOSE MONITORING SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Allure, Allure RF, Allure Quadra, Allure Quadra RF - PM3120, PM3222, PM3140, PM3242

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MCGHAN SALINE-FILLED BREAST IMPLANTS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT ABDOMINAL STENT GRAFT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA SERIES DEFIBRILLATION LEAD SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS HBV TEST

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject Trabecular Micro-Bypass System

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

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SMARTTOUCH SF Uni/Bi-Directional Navigation Catheter

System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx Downstream System

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·ADAPTER 2D MATRIX BARCODE VERIFICATION SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·ZYDERM COLLAGEN IMPLANT (ZYDERM CI)