Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADAR VISION EXCIMER LASER SYSTEM

Pump, Drug Administration, Closed Loop

FDA Pre-Market Approval

FDA Class 3 ·GENESA(R) SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·QUADRIPOLAR PACING PAS (QUAD PAS)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRT IPG

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD, EVERA S VR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG

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

FDA Pre-Market Approval

FDA Class 3 ·MT PAS ACUITY X4

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS 3-PCS MONOFOCAL LENS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN (MODEL MMT-522/MMT-522K/MMT-722/MMT-722K/MMT-523/MMT-523K/MMT-723/MMT-723K)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·TSLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM SYSTEM.

Ring, Endocapsular

FDA Pre-Market Approval

FDA Class 3 ·Capsular Tension Ring (CTR) and RingJect

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programmer Software

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Evoke® SCS System