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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 CRT-D, PROTECTA CRT-D, CONSULTA CRT-D, CONCERTO II CRT-D, MAXIMO II CRT-D
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS344
Date Received12/19/2012
Decision Date09/25/2013
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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