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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.
 
Device, BRAVA QUAD, CONCERTO II , CONSULTA , MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S & XT, VIVA S & XT CRT-D'S
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS466
Date Received09/02/2014
Decision Date11/14/2014
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE DESIGN AND MANUFACTURING CHANGES OF THE 9-PIN FEEDTHROUGH SUBASSEMBLY IN THE PMA SUPPLEMENTS.
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