Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR INTRAOCULAR LENSES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 600/700/650/800/900 IPGS/ENPULSE/SIGMA/MEDTRONIC 350 SERIES/AT500/ENRHYTHM/ADAPTA/VERSA/SENSIA/RELIA IPGS

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DURASPHERE INJECTABLE BULKING AGENT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK LOWPOROSITY VALVED CONDUIT

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN ABILITY LEAD, ATTAIN PERFORMA QUADRIPOLAR LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·Anchoring Sleeve Kit, SelectSecure Lead

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT THORACIC STENT GRAFT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX MRI SURESCAN LEAD

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN Ultrasound Bone Healing System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW/OTW/CS LEAD

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas BRAF V600 Mutation Test

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·methafilcon A and methafilcon B Soft (Hydrophilic) Extended Wear Contact Lenses

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

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, AND SENSIA IPG'S

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM HE/3/VITALITY/2/AVT/CONFIENT/TELIGEN