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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.
 
DeviceDYNAGEN CRT-D, DYNAGEN X4 CRT-D,INOGEN CRT-D, INOGEN X4 CRT-D,ORIGEN CRT-D, ORIGEN X4 CRT-D, INCEPTA TM ICD,ENERGEN TM I
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP010012
Supplement NumberS388
Date Received05/18/2015
Decision Date06/04/2015
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  
ENHANCEMENT OF THE IS-1 AND IS-4 COIL SPRING INSPECTIONS AT THE SUPPLIER BY ADDING AN AUTOMATED VISION (AVI) SYSTEM.
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