Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·In.Pact Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Chatheter

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra Transcatheter Pacing System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL VASCULAR CLOSURE DEVICE

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FLEXTEND BIPOLAR ELUTING EXTENDABLE/RETRACTABLE PACING LEADS,MODELS 4086, 4087, 4088

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

FDA Pre-Market Approval

FDA Class 3 ·THINLINE II AND FINELINE II STEROX LEADS AND FINELINE II EZ STEROX LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 2 LV-1, IS-1, 3 LV-1, 3 IS-1 LEFT VENTRICLAR HEART FAILURE LEADS, AND ACUITY SPIRAL LEADS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·TRIFECTA VALVE

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ACUITY STEERALE LEADS MODELS: 4554, 4555

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE EZ IS-1 AND 4-SITE EZ QUADRIPOLAR ACTIVE FIXATION LEADS

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·Urinary Control System

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·Inflatable Penile Prosthesis

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·H.E.L.P. PLASMAT FUTURA SYSTEM

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL Hemostatic Matrix/ Floseal Special Applicator Tips

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·ACUITY SPIRAL LEAD, ACUITY X4 LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE IS-1 and ENDOTAK RELIANCE 4-SITE LEAD

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·Artegraft Collagen Vascular Graft