Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA/VERSA/SENSIA/RELIA

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·RESTORE IMPLANTABLE NEUROSTIMULATORS

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM ICON PATIENT PROGRAMMER

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·PERSONAL THERAPY MANAGER (MYPTM)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA FAMILY OF IMPLANTABLE STIMULATORS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Diamondback 360 Coronary Orbital Atherectomy Device (OAD)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·X Series, Propaq MD, and R Series

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D 8750, PARADYM RF CRT-D 9750 (ZL 102), INTENSIA CRT-D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL102), INTENSIA VR ICD, INTENSIA DR

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY FOR URINARY CONTROL

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SPINAL CORD STIMULATION SYSTEMS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) ACUVUE OASYS Brand Contact Lenses

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PUNCTUA ICDS,TELIGEN ICDS,ENERGEN ICDS,INCEPTA ICDS,ORIGEN ICDS,INOGEN ICDS,DYNAGEN ICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PUNCTUA CRT-DS,COGNIS CRT-DS,ENERGEN CRT-DS,INCEPTA CRT-DS,ORIGEN CRT-DS,INOGEN CRT-DS,DYNAGEN CRT-DS

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·X Series, R Series, Propaq MD, and AED Pro

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES