Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE(TM) COLLATAPE(R) ABSORBABLE COLLEGAGEN WOUND DRESSINGS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK 2 MONORAIL PTCA CATHETERS

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·ExAblate 4000 System (Exablate Neuro or the system)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·INSIGNIA AND CONTAK RENEWAL TR PULSE GENERATORS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·APEX MONORAIL AND OVER-THE-WIRE PTCA DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R)TELESCOPE(TM) SINGLE OPERATOR BALLOON

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Evolut FX device

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CHAMPION WRAP PTCA CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 2490E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·2490D/E CARELINK MONITORS & MODEL 2491 DDMA SOFTWARE FOR INSYNC MARQUIS & MAXIMO VR/DR CAPABILITY

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·MENTOR TITAN INFLATABLE PENILE PROSTHESIS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515)

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA ARTIFICAL SKIN DERMAL REGENERATION TEMPLATE

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA Pre-Market Approval

FDA Class 3 ·NeuRX Diaphragm Pacing System (DPS)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 2490E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·PROPEL AND PROPEL MINI SINUS IMPLANTS