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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.
 
DeviceBRAVA/VIVA S/VIVA XT CRT-D
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS356
Date Received02/07/2013
Decision Date03/05/2013
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
(1) FACTORY WORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1; (2) MODIFICATION OF CONTROLLED ENVIRONMENT AREA; (3) NEW PRESSURE TESTER AT SMO FACILITY; AND (4) TEMPORARY GOWNING AREA AND TEMPORARY WALLS AND RELOCATION OF THE MILLING ROOM.
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