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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.
 
DeviceGORE CARDIOFORM Septal Occluder;
Generic NameTranscatheter septal occluder
ApplicantW.L. GORE & ASSOCIATES,INC
32360 N NORTH VALLEY PARKWAY
PHOENIX, AZ 85085-1505
PMA NumberP050006
Supplement NumberS054
Date Received10/03/2016
Decision Date10/24/2016
Product Code MLV 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Implementation of an alternate transverse film expansion machine with an in-line, automated camera inspection system.
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