Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR IPG AND ADVISA DR MRI IPG

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF CONTACTR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMESSENGER II-S AND CARDIOMESSENGER II-S TLINE HOME MONITORING DEVICES

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MOSIAC PORCINE BIOPROSTHESIS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC; INSYNC III; ATTAIN LEAD; ATTAIN OTW LEAD

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN ABILITY LEAD, ATTAIN PERFORMA LEADS

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM STS SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/VERSA IPG

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SYNCRA/CONSULTA CRT-P

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PERCEPTA QUAD CRT-P MRI SURESCAN, SERENA QUAD CRT-P MRI SURESCAN, SOLARA QUAD CRT-P MRI SURESCAN, IMPLANTABLE PULSE GENE

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·Barostim System

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

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

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Astron Pulsar/Pulsar-18 Stent System

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·Attune Revision Tibial Augments

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DBS ACCESSORIES,DBS EXTENSIONS,DBS LEADS,DBS NEUROSTIMULATORS IMPLANTABLE,DBS NEUROSTIMULATORS SOLETRA FAMILY