Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment

System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

FDA Pre-Market Approval

FDA Class 3 ·ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (RX & OTW), XIENCE NANO EECSS (RX)

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control anti-HBc

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MINILINK TRANSMITTER (MMT-7703), IPRO DIGITAL RECORDER (MMT-7709) AND IPRO2 RECORDER (MMT-7741)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE, PROVISC PACKAGED IN DUOVISC VISCOELASTIC SYSTEM AND DISCOVISC OPHTHALMIC VISCO

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards pericardial Mitral Bioprosthesis and Edwards INSPIRIS RESILIA Aortic V

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA, CONCERTO II, MAXIMO II CRT-D AND SECURA, VIRTUOSO II, MAXIMO II ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker Devices: ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA II supported

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Freezor Cardiac CryoAblation Catheter, Freezor Xtra Cardiac CryoAblation Catheter and Freezor MAX Cardiac CryoAblation

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY & RHAPSODY SR/REPLY SR/DR/REPLY SR/DR (V2)/ESPRIT SR/DR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Platform, CareLink SmartSync MRI Host Application, CareLink SmartSync Common Application and Patient

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FLOUR AND AVITENE ULTRAFOAM CAST MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH)

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL MECHANICAL HEART VALVE/SJM MASTERS SERIES & SJM REGENT HEART VALVES

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL Murex Anti-HBc and LIAISON® XL Murex Control Anti-HBc

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELECTROPHYSIOLOGY CATHETER & THERMOCOOL SF NAV CATHETER

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL 3, SYNERGY, RESTORE PRIME & PRIME ADVANCED FAMILY OF IPGS OR IMPLANTABLE NEUROSTIMULATOR