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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.
 
DeviceINSYNC FAMILIES OF ICDS/CONCERTO CRT-D/MAXIMO II/CONSULTA/CONCERTO II CRT-D
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS134
Date Received11/20/2008
Decision Date12/17/2008
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  
REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING IN THE CONTROLLED ENVIRONMENT ARE AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN JUNCOS, PUERTO RICO.
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