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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; GORE® CARDIOFORM ASD Occluder
Generic NameTranscatheter septal occluder
ApplicantW. L. Gore & Associates, Inc.
32360 N. N. Valley Pkwy.
Phonix, AZ 85085
PMA NumberP050006
Supplement NumberS119
Date Received07/07/2026
Decision Date08/03/2026
Product Code MLV 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifications to the Instructions for Use (IFU) for the GORE® CARDIOFORM Septal Occluder and GORE® CARDIOFORM ASD Occluder to add instructions of optional delivery system manipulation techniques in the event of a delayed lock has occurred at device deployment
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