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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceCobalt XT DR MRI SureScan (DDPA2D4 and DDPA2Dl); Cobalt DR MRI SureScan (DDPB3D4 and DDPB3Dl); Crome DR MRI SureScan (DD
Generic Nameimplantable cardioverter defibrillator (non-crt)
8200 coral sea street n.e.
ms mvs11
mounds view, MN 55112
PMA NumberP980016
Supplement NumberS713
Date Received07/01/2019
Decision Date04/23/2020
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
Approval for Cobalt XT, Cobalt, and Crome MRI SureScan Implantable Cardioverter Defibrillator (ICD) and ICD with Cardiac Resynchronization (CRT-D) Systems.
Post-Approval StudyShow Report Schedule and Study Progress