Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Intuity Elite Valve System

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MASTERS SERIES VALVE: PTFE SEWING CUFF

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM Master Series Mechanical Heart Valve with Silzone Coating, Expanded Polyester Cuff with Silzone Coating, HP Cuff wit

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·42 FR VENTRICULAR CANNULA WITH INTEGRATED SEWING CUFF

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX MRI LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECTSECURE LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO LEAD, SPRINT QUATTRO LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·CMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic)

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MECHANICAL HEART VALVE SJM(R) MASTER SERIES (EXPANDED SEWING CUFF)

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·DAVOL LONG TERM EPIDURAL CATHETER, CATHETER WITH VITACUFF ANTIMICROBIAL CUFF AND REPAIR KIT

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE AND CONDY LAR PROSTHESIS SYSTEM

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA EMINENCE/CONDYLAR PROSTHESIS SYSTEM

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS(TM)

Glenoid Fossa Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS