Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·DUETT PRO SEALING DEVICE (MODEL 1010) AND DIAGNOSTIC DUETT PRO SEALING DEVICE (MODEL 2210)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AV, VENTAK PRIZM DR/VR, VITALITY, CONFIENT, LIVIAN, & TELIGEN FAMILIES OF ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, and Crome MRI CRT-D

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System

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

FDA Pre-Market Approval

FDA Class 3 ·TactiCath Quartz Contact Force Ablation Catheter and TactiCath Contact Force Ablation Catheter, Sensor Enabled

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valves and Edwards SAPIEN 3 Ultra Transcatheter Heart Valves

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 CATHETER,THERAPY 8MM THERMISTOR ABLATION CATHETER, SAFIRE TX, AND ASSOCIATED CABLES

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO SV AND OC OVER-THE-WIRE (OTW) STENT DELIVERY SYSTEMS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD, LIVIAN, COGNIS, ENERGEN, PUNCTUA AND INCEPTA CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEFIBRILLATOR SYSTEMS

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

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

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax

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 Flutter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER IIXP/BLAZER PRIME XP ABLATION CATHETERS AND EPT-1000 XP CARDIAC ABLATION CONTROLLER