Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·Woven EndoBridge Aneurysm Embolization (WEB) System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MEMORYGEl BREAST IMPLANTS

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Spiration® Valve System

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MEMORYSHAPE BREAST IMPLANTS

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr., LVIS EVO

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead, Attain OTW L V Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CR T-P, Seren

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX/OTW TRISTAR CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS/EXPRESS 2 MR & OTW CORONARY STENT SYSTEMS

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK RX AND OTW VISION CORONARY STENT SYSTEMS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE LOW VISCOSITY INJECTABLE IMPLANT; RADIESSE (+) LIDOCAINE DERMANL FILTER

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM Monorail & OTW

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY SYSTEM (RX AND OTW)

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX/OTW DUET CORONARY STENT SYSTEMS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK PORCINE BIOPROSTHESIS, LOW POROSITY VALVED CONDUIT MODEL 105

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK ULTRA RX AND OTW CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK RX TETRA/OTW TETRA CORONARY STENT SYSTEM