Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP. PARADIGM REAL-TIME REVEL INSULIN PUMP.

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK PROGRAMMER MODEL 2090 AND MODEL 9790/C PROGRAMMER

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke SCS System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN EL, INOGEN EL, ORIGEN EL ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN EL/MINI; INOGEN EL/MINI; ORIGEN EL/MINI; AUTOGEN EL; VIGILIANT EL; PERCIVA; RESONATE EL/HF; PERCIVA HF; MOMENTUM

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

FDA Pre-Market Approval

FDA Class 3 ·PG VALITUDE CRT-P IS1 EL, IS4 EL, PG VISIONIST CRT-P IS1 EL, LV1 EL, IS4 EL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RESONATE™ HF, RESONATE™ EL, MOMENTUM™ EL, VIGILIANT™ EL, PERCIVA™ HF, PERCIVA™

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Dynagen Mini ICD, Inogen Mini/EL ICD, Origen Mini/EL ICD, Dynagen EL ICD, Autogen EL ICD, Vigilant EL ICD, Perciva ICD,

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN EL, INOGEN EL, DYNAGEN EL ICD'S ; ORIGEN MINI, INOGEN MINI, DYNAGEN MINI ICD'S

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ELCA CORONARY LASER ATHERCOTOMY CATHETER (ELCA 2.0 VITESSE ELL)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke SCS System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Dynagen EL & Mini, Inogen EL & Mini, Origen EL & MIni IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICD Inogen VR, ICD Dynagen VR, ICD Dynagen DR, Momentum EL ICD VR, Momentum EL ICD DR, Vigilant EL ICD VR, Vigilant EL I

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

FDA Pre-Market Approval

FDA Class 3 ·Valitude CRT-P IS1/IS4 EL, Visionist CRT-P IS1 El and Visionist CRT-P LV1 EL

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN EL. DYNAGEN MINI, INOGEN EL, INOGEN MINI, ORIGEN EL, ORIGEN MINI ICD'S