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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 ASD Occluder
Generic NameTranscatheter septal occluder
ApplicantW.L. GORE & ASSOCIATES,INC
32360 N NORTH VALLEY PARKWAY
PHOENIX, AZ 85085-1505
PMA NumberP050006
Supplement NumberS071
Date Received11/06/2018
Decision Date05/28/2019
Product Code MLV 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of the GORE® CARDIOFORM ASD Occluder configuration to the GORE® HELEX® Septal Occluder product line.
Post-Approval StudyShow Report Schedule and Study Progress
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