MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD

FDA premarket approval P980016/S399 · decided 2013-03-20

Approval details

PMA number

P980016

Supplement

S399

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

Medtronic Cardiac Rhythm Disease Management

Date received

2013-02-21

Decision date

2013-03-20

Days to decision

27 days

Decision code

OK30

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

Statement

IC MANUFACTURE TEST CHANGES FOR THE ADVISA DR IPG A4DR01, ADVISA MRI IPG A2DR01,CONSULTA CRT-P C4TR01, SYNCRA CRT-P C2TR01, CONCERTO II CRT-D D274TRK, CONSULTA DF4 ICD D204TRM, CONSULTA ICD D224TRK,MAXIMO II CRT-D D264TRM, D284TRK, PROTECTA CRT-D D334TRG, D334TRM, PROTECTA XT CRT-D D314TRG, D314TRM, MAXIMO II ICD D264DRM, D264VRM, D284DRG, D284VRC, PROTECTA ICDD334DRG, D334DRM, D334VRG, D334VRM, PROTECTA XT ICD D314DRG, D314DRM, D314VRG, D314VRM, SECURA ICD D204DRM, D204VRM, D224DRG, D224VRC, VI