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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 NameINCEPTA,ENERGEN,PUNCTUA ICDS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP960040
Supplement NumberS300
Date Received07/01/2013
Decision Date07/30/2013
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the vacuum bake duration and number of optional re-bakes for an electrical component in the pulse generators for the devices.
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