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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 NumberS100
Date Received06/06/2022
Decision Date07/06/2022
Product Code MLV 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.
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