Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DIVA FAMILY INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE 11, VITA DDDR, VITA DDD AND VITA VVIR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DIVA FAMILY (INCLUDES DIAMOND II, RUBY II, TOPAZ II, JADE II, VITA DDDR, VITA DDD AND VITA VVIR) DEMA FAMILY (INCLUDES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Diva family(includes Diamond II, Ruby II, Topaz II, Jade II, Vita DDDR, Vita DDD and Vita VVIR) Dema family, Selection A

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·CRYOLIFE BIOGLUE SURGICAL ADHESIVE

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon System

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS PA Sensor and Delivery Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·CRT-Ds (Cardiac Resynchronization Therapy Defibrillator) Platinium

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ICDs (Implantable Cardioverter Defibrillator) Platinium VR/DR

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE VENTRICULAR ASSIST SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Septal Occluder

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Sapien 3 Transcatheter Heart Valve

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG; Attesta SR MRI IPG; Relia IPG; Sphera SR MRI IPG

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMVISC AND AMVISC PLUS OPHTHALMIC VISCOSURICAL DEVICE (OVD)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE AND CONDY LAR PROSTHESIS SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENRHYTHM IPG