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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 NamePUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, CARDIAC RESYNHRONIZATION THERAPY-DEFIBRILLATOR
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP010012
Supplement NumberS402
Date Received09/30/2015
Decision Date10/21/2015
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Eliminate an equipment check performed on equipment used to test parylene coating thickness of batteries and capacitors used in the device models.
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