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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 NameORIGEN EL ICD, MINI ICD, DYNAGEN EL ICD, MINI ICD, INOGEN EL ICD, MINI ICD, INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP960040
Supplement NumberS353
Date Received07/29/2015
Decision Date08/21/2015
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 
Addition of an alternate semi-automated 'thickness and loading' process step to the battery manufacturing line.
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