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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 NameINSYNCII/ III PROTECT/INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO/CONCERTO/MAXIMO II
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS121
Date Received09/17/2008
Decision Date10/10/2008
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to perform wafer saw and die visual processing at the supplier.
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