Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM, JEWEL, MICRO JEWEL, JEWEL PLUS, MICRO JEWEL II, PCD

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella Ventricular Support Systems

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI, ENRHYTHM MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEGEND PLUS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PCD

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE INTERCEED Absorbable Adhesion Barrier

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITATRON (IPG'S)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEGEND PLUS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVE LIGHT EX500 LASER SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST, GEM, GEM II, GEM III, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, ONYX, PROTECTA DF4, PROTECTA, PROTECTA XT DF4,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·JEWEL AF, GEM III AT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO, RIGHT VENTRICULAR LEAD INTEGRITY ALERT, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC UCD, INSYNC II MARQUIS, INSY

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP Flex with SmartAssist

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ELITE, ELITE II, MINUET, PREVA, PREVA D, PRODIGY, SYNERGYST II, THERA, THERA-I, VITATRON LEGACY, VITATRON LEGACY II

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACTIVITRAX,ACTIVITRAX II,ACTIVITRAX E,LEGEND,LEGEND II,MICRO MINIX,MINIX ST,PREMIER,PREVAIL,VITATRON LEGACY

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, ADVISA, AT500, ENPULSE, ENRHYTHM, KAPPA 600, KAPPA 650, KAPPA 700, KAPPA 800, KAPPA 900, RELIA, SENSIA, SIGMA,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Visi

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 800, KAPPA 900, KAPPA 650, KAPPA 700, KAPPA800, KAPPA 900, RELIA, SENSIA, SIGMA, VERSA JEWEL AF GEM III AT