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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/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS281
Date Received11/14/2011
Decision Date12/13/2011
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  
UPDATED VERSION OF SOFTWARE WHICH SUPPORTS THE HYBRID SLANT HANDLER USED FOR TESTING OF HYBRID SUBASSEMBLIES.
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