FDA Pre-Market Approval

INSYNC SENTRY CRT-D/CONCERTO ICD/CONSULTA CRT-D/CONCERTO II CRT-D/MAXIMO II CRT-D/PROTECTA/XT CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/II/II M4/PROTECTA/XT/PROTECT XT M4/PROTECTA M4/SECURA/SECURA M4/VIRTUOSO/II ICDS

FDA Pre-Market Approval

INSYNC/INSYNC MARQUIS/INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II CRT-D

FDA Pre-Market Approval

INSYNC ICD & INSYNC MARQUIS, INSYNC II & III MARQUIS FAMILY & INSYNC II PROTECT & INSYNC SENTRY & MAXIMO FAMILY

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

FDA Pre-Market Approval

FDA Class 3 ·ICD ORIGEN CRT-D DF4/IS1, DF/IS1/ DF1/IS1/IS4, AND DF4/IS1/IS4, MMENTUM CRT-D IS1 DF4 IS1

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR (ZL 102) Intensia VR ICD, Intensia DR, Platinium VR, Platinium DR

FDA Pre-Market Approval

INSYNC/INSYNC MARQUIS/II/III/INSYNC PTOTECT II/III/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF ICD'S, GEM FAMILY, MICRO JEWEL II, MICRO JEWEL, JEWEL AND JEWEL PLUS FAMILY, PCD FAMILY,JEWEL CD 720

N'VISION®

FDA UDI

MEDTRONIC, INC.·00613994452191·PRGMR 8840 NVISION PHYSICIAN LOANR INSRT

N'VISION™

FDA UDI

MEDTRONIC, INC.·00613994997838·PRGMR 8840 N'VISION PHYSICIAN HANDHELD

N'VISION™

FDA UDI

MEDTRONIC, INC.·00613994997845·PRGMR 8840 N'VISION PHYSICN W LOANER INS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO ICD, CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA DF-DF-4, PROTECTA XT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR & SR,, EVERA XT DR & VR , MAXIMO II, PROTECTA , PROTECTA XT, SECURA, & VIRTUOSO II DR/VR ICD'S

FDA Pre-Market Approval

BRAVA CRT-D, CONCENTOIICRT-D, CONSULTA ICD,MAXIMOII CRT,PROTECTA CRT-D, PROTECAXT CRT-D,VIVA S CRT-D,VIVAXT CRT-D

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Various models of dual chamber ICDS in the Ilivia, Intica, Inlexa Families, Various models of CRT-Ds and Non- CRT-Ds in

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR, VR,; EVERA XT DR, EVERA XT VR , MAXIMO II , PROTECTA , PROTECTA XT, SECURA; AND VIRTUOSO II D/RVR ICD'S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA MRI, EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR, VISIA AF MRI VR, VISIA AF VR ICD.

QMD Services GmbH

Notified body

🇦🇹 Austria·6 Manufacturers·1 Basic UDI-DI

FDA Pre-Market Approval

BRAVA CRT-D, CONCERTA II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA/PROTECTA XT CRT-D S/VIVA XT CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR,EVERA S VR,EVERA XT DR,EVERA XT VR,MAXIMO II,PROTECTA,PROTECTA XT,SECURA,VIRTUOSO II DR/VR ICDS