Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare® Ventricular Assist System or HeartWare® System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM OR CABLE MODIFICATION

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS FOR USE AT ONE OR TWO LEVELS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Mobi-C Cervical Disc Prosthesis for use at One or Two Levels

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS FOR USE AT ONE OR TWO LEVELS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·ARROW OR PUMP HEATER & AP-07009 FLEX TIP PLUS INTRASPINAL KIT

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) or (tisilfocon A) Contact Lenses for Overnight Wear

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Philips HeartStart FR3 Defibrillator

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR RIGHT ATRIAL PACEMAKER ELECTRODES, DEXTRUS, SETROX, TILDA, SAFIO

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL 3/SYNERGY/RESTORE PRIME/PRIME ADVANCED FAMILY OF IMPLANTABLE PULSE GENERATOR OR IMPLANTABLE NEUROSTIMULATOR

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL3,SYNERGY,RESTORE PRIME & PRIME ADVANCED FAMILY OF IMPLANTABLE PULSE GENERATOR OR INPLANTABLE NEUROSTIMULATOR

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN THV WITH RETROFLEX FOR INOPERABLE PATIENTS AND WITH RETROFLEX OR ASCENDRA FOR HIGH RISK OPERABLE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Permanent Implantable, Drug-Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Ele

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CYPHER SIROLIMUS CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER STENT