Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE® /IMMULITE® 1000 AFP and IMMULITE® 2000 AFP

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

FDA Pre-Market Approval

FDA Class 3 ·Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP (MR Conditi

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System Bowel Control

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK 8 Coronary Stent System, MULTI-LINK 8 SV/ 8 LL Coronary Stent System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Innova Vascular Self-Expanding Stent System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Durata, Optisure

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris® Spinal Cord S

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II INFUSION PUMP

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN ABILITY LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SETROX S 45, SETROX S 53, SETROX S 60, DEXTRUS 4135, DEXTRUS 4136, DEXTRUS 4137, SAFIO S 53, SAFIO S 60, TILDA JT45, TIL

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MYNXGRIP VASCULAR CLOSURE DEVICE

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ACUITY STEERABLE IS-1 LEADS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS CORONARY STENT SYSTEM & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 1 PIECE IOL MODEL ZCB00

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·OVATIO VR/DR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)