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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINCEPTA, ENERGEN, PUNCTUA, DYNAGEN,INOGEN,ORIGEN CRT-D
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP010012
Supplement NumberS396
Date Received07/13/2015
Decision Date08/08/2015
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADD AN ADDITIONAL INSPECTION STEP TO PULSE GENERATOR CASE HALF MANUFACTURING, ALONG WITH ASSOCIATED SPECIFICATION AND INSPECTION CRITERIA, THAT WILL ALLOW PULSE GENERATOR CASE HALF DISCONTINUITIES TO BE DISTINGUISHED FROM DENTS.
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