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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.
 
DevicePROTECTA XT ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II ICD, MAXIMO II ICD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
ms mvs11
mounds view, MN 55112
PMA NumberP980016
Supplement NumberS394
Date Received12/19/2012
Decision Date09/25/2013
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ADDING NON-MEDTRONIC DEFIBRILLATION LEADS TO RIGHT VENTRICULAR LEAD INTEGRITY ALERT (RV LIA) LABELING.
Post-Approval StudyShow Report Schedule and Study Progress
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