Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE WIRE)

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY TINED LEADS, MODELS 3889 AND 3093

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LIFE PULSE HIGH FREQUENCY VENTILATOR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 5348 SINGLE CHAMBER TEMPORARY PACEMAKER, MODEL 5388 DUAL CHAMBER TEMPORARY PACEMAKER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Freezor Cardiac Cryoablation Catheter; Freezor Xtra Surgical Cardiac Cryoablation Device; Freezor MAX Cardiac Cryoablati

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL BIOCOR AND BIOCOR SUPRA VALVES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COSMO, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·CORMET HIP RESUFACING SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPI EPICARDIAL STEROID ELUTING PACING LEAD

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Cobas 4800 BRAF V600 Mutation Test

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·ATS 3F AORTIC BIOPROSTHESIS

Bronchial Thermoplasty System

FDA Pre-Market Approval

FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY AB ACETABULAR SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·CPR Stat-Padz Electrode and CPR-D Padz Electrode

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·S.M.A.R.T. CONTROL Nitinol Stent System; S.M.A.R.T. RADIANZ Vascular Stent System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERCARDIAL BIOPROSTHESIS