System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH TX2 TAA ENDOVASCULAR GRAFT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Zenith Dissection Endovascular System

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SYNVISC (HYLAN G-F 20)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX MINI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK

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

FDA Pre-Market Approval

FDA Class 3 ·FINLINE LEAD FAMILY

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP RX/ FLEXTEND LEAD FAMILY

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity™ HPV Assay

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK LEAD FAMILY

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·HYALGAN

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·END CAP 6701,EPICARDIAL PATCH LEAD 6721L, 6721M, 6721S,SIZING SLEEVE 6920,UPSIZING SLEEVE 6925

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER, DEFIBRILLATION SUPPORT DEVICE (DISD), END CAP, EPICARDIAL PATCH LEAD, SIZING SLEEVE, UPSIZING SLEEVE

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH AAA ENDOVASCULAR GRAFT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED2 PUMP FEED-THROUGHS & CATHETER ACCESSORIES

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System