Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

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

FDA Pre-Market Approval

CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR IPG, ADVISA MRI IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant™, Neutrino™ NxT, Gallant™, and Entrant™ (NGQ) ICDs and CRT-Ds DF-1 Model Expansion

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC PROTECTA XT/PROTECTA/SECURA/MAXIMO II DR DF4 DEVICES (D314DRM, D334DRM, D204DRM AND D264DRM)

FDA Pre-Market Approval

CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-D

FDA Pre-Market Approval

CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC PROTECTA XT/PROTECTA/SECURA/MAXIMO II DR DF4 DEVICES (D314DRM, D334DRM, D204DRM AND D264DRM)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant™, Neutrino™ NxT, Gallant™, and Entrant™ (NGQ) ICDs and CRT-Ds DF-1 Model Expansion

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

FDA Pre-Market Approval

FDA Class 3 ·Avant™, Neutrino™ NxT, Gallant™, and Entrant™ (NGQ) ICDs and CRT-Ds DF-1 Model Expansion

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 6935

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Visia AF MRI DF1 ICD, Visia AF MRI VR ICD, and Visia AF VR ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI XT DR SureScan ICD DDMB1D1, Evera MRI XT VR SureScan ICD DVMB1D1, Evera MRI S DR SureScan ICD DDMC3D1, Evera M

FDA Pre-Market Approval

MEDTRONIC PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 DEVICES (D314TRM, D334TRM, D204TRM AND D264TRM)

FDA Pre-Market Approval

MEDTRONIC PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 DEVICES (D314TRM, D334TRM, D204TRM AND D264TRM)

HX 2028254-1

Certificate

IVDR QMS·DFI Co.,Ltd.·TÜV Rheinland LGA Products GmbH

0425-MED-003637-00

Certificate

MDD Annex II (excluding section 4)·D.Z. MEDICALE S.R.L.·ICIM S.P.A.·11 Basic UDI-DIs

0425-;MED-003637-00

Certificate

MDD Annex II (excluding section 4)·D.Z. MEDICALE S.R.L.·ICIM S.P.A.·1 Basic UDI-DI

CE:0425-MED-003637-00

Certificate

MDD Annex II (excluding section 4)·D.Z. MEDICALE S.R.L.·ICIM S.P.A.·1 Basic UDI-DI