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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D CONCERTO
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS218
Date Received10/15/2010
Decision Date11/10/2010
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of updated hardware and software for the barcode/optical character recognition labeler system used to identify integrated circuit component wafers at your hybrid supplier.
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