Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Mentor MemoryShape Breast Implants

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Supera Peripheral Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·ThermoCool SmartTouch

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Cobas EGFR Mutation Test and Cobas EGFR v2 Mutation Test

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3307 V1.2A PROGRAMMER SOFTWARE FOR THE MODEL 3500/3510 PROGRAMMERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Webster Diag./Ablation Deflectable Tip Catheter

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX Injectable Gel

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS

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

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Tendril STS 2088TC Lead

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

FDA Pre-Market Approval

FDA Class 3 ·Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Zeiss 3-piece Hydrophobic Acrylic Intraocular lens (IOL)

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STYLES 31-34 POSTERIOR IOLS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM