Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR/SR MRI IPG, Astra XT DR/DR MRI IPG and Azure S SR MRI IPG XT DR/SR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, and Sphera SR MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, and Sphera SR MRI IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Quad CRT-P MRI SureScan / Percepta CRT-P MRI SureScan / Serena Quad CRT-P MRI SureScan / Splar Quad CRT-P MRI S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Attesta DR MRI IPG/Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG/Sphera

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt XT DR ICD MRI SureScan, Cobalt DR ICD MRI SureScan, Crome DR ICD MRI SureScan, Cobalt XT VR ICD MRI SureScan, Cob

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MIR IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ASTRA S DR MRI IPG X3DR01; ASTRA S SR MRI IPG X3SR01; ASTRA XT DR MRI IPG X1DR01; ASTRA XT SR MRI IPG X1SR01

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta Versa Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, En

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra XT/S DR MRI IPG, Astra S/XT SR MRI IPG, Azure S/XT DR MRI IPG, Azure S/XT SR MRI IPG

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

FDA Pre-Market Approval

FDA Class 3 ·AMPLIA MRI, AMPLIA MRI QUAD, BRAVA, BRAVA QUAD, COMPIA MRI,COMPIA MRI QUAD, VIVA QUAD S, VIVA QUAD XT, VIVA S, VIVA XT C

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ASTRA S DR MRI IPG X3DR01, ASTRA S SR MRI IPG X3SR01, ASTRA XT DR MRI IPG X1DR01, ASTRA XT SR MRI IPG X1SR01

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO VALITUDE™ MRI: L110, L111, L131;PROPONENT VALITUDE™ MRI: L210, L211, L231; ACCOLADE VALITUDE™ MRI: L310, L311,

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

FDA Pre-Market Approval

FDA Class 3 ·Claria MRI CRT-D QUAD SureScan; Amplia MRI Quad CRT-D SureScan; Compia MRI CRT-D SureScan