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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 CRT-DS/CONCERTO
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP010031
Supplement NumberS203
Date Received06/18/2010
Decision Date07/16/2010
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGES IN PLATINUM FLOW ON COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) AT THE SUPPLIER LOCATION.
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