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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 NamePROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D ICDS
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS311
Date Received05/31/2012
Decision Date06/25/2012
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Update to the vendor inspection of a flex component, a change to the die attach cure process and removal of parallel gap welding line testing.
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