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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.
 
DeviceCONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D/DF4, PROTECTA CRT-D/DF4/XT CRT-D/XT DF4
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS306
Date Received05/11/2012
Decision Date06/04/2012
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  
INCORPORATE PLATING BAKE TEST AS PART OF THE MONITORING CONTROL PLAN PERFORMED AT THE SUPPLIER.
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