Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CARDIAC RESYNCHRONIZATION THERAPY PACING (CRT-P) & INSYNC III CRT-P

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·E-LUMINEXX VASCULAR STENT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards INTUITY Elite Valve, Edwards INTUITY Elite Valve Delivery System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA, KINETRA AND SOLETRA FAMILIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA IPGS, SIGMA IPGS, ENPULSE IPGS, ENRHYTHM IPGS, AT500 PACING SYSTEM, ADAPTA/SENSIA/VERSA IPGS AND RELIA IPG

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDURANT,ENDURANT II AND ENDURANT II AOTYO-UNI-LIAC (AUI) STENT GRAFT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·AXSYM CORE 2.0 (LN 8B88)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·PREVELLE SILK

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FREQUENCY TORIC & SPHERE (METHAFILCON A 55%) SOFT (HYDROPHILIC) CONTACT LENSES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DISCOVERY/MERIDIAN

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS EXTENSIONS, DBS LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM/VITALITY

Stent, Coronary

FDA Pre-Market Approval

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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation System and Pisces, Specify, and Vectris Spinal Cord

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Saline-Filled Breast Implants

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Symfony Toric II OptiBlue Extended Range of Vision (ERV) IOL

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Preveleak Surgical Sealant

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Helistat and Helitene Absorbable Collagen Hemostatic Agents

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK 8, MULTI-LINK 8 SV/LL CORONARY STENT SYSTEMS