FDA Pre-Market Approval

CONCERTO/CONCERTO II/CONSULTA/INSYNC II/III MARQUIS/MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PRODIGY, MINUET, SYNERGYST II, & VARIOUS FAMILIES/MODELS OF ELITE, PREVA, THERA, & VITATRON LEGACY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO II/CONSULTA/INSYNC II MARQUIS/III MARQUIS/INSYNC MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SENSE LEAD, CAPSURE SP LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ACTIVITRAX

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI, Evera, Marquis, Secura, Maximo II, Intrinsic, Protecta, Protecta XT, Virtuoso II, VIsia AF, Primo DR and VR M

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, Cobalt

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, & PROTECTA XT CRT-D'S

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

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CapSure VDD 2 Lead, Vitatron Brilliant S+ VDD Lead

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, Cobalt

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PROTECTA XT CRT-D AND PROTECTA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION; MODEL SW009

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI/MRI Quad CRT-D's; Brava CRT-D; Compia MRI/MRI Quad CRT-Ds; Concerto II CRT-D; Consulta CRT-D; Maximo II CRT-D

FDA Pre-Market Approval

CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·, BRAVA QUAD, CONCERTO II , CONSULTA , MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S & XT, VIVA S & XT CRT-D'S

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SENSE BIPOLAR LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI ICD,S DR ICD, S VR ICD, XT DR ICD, XT VR ICD; Mirro MRI DR ICD, VR ICD; Primo MRI DR ICD,VR ICD: Visia AF MRI

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Steroid TIP(TM) Model 4503 & 4003 Transvenous Pacing

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PRODIGY IPG