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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, INOGEN CRT-D, ORIGEN CRT-D
ApplicantBoston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP010012
Supplement NumberS404
Date Received11/09/2015
Decision Date12/07/2015
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  
ADDITION OF A NEW MANUFACTURING INSPECTION TO VERIFY THE POLARITY OF THE DISCRETE CAPACITOR ARRAY COMPONENT ON THE PRINTED CIRCUIT BOARD.
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