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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, GORE® CARDIOFORM Septal Occluder
Generic NameTranscatheter septal occluder
ApplicantW. L. Gore & Associates, Inc.
32360 N. N. Valley Pkwy.
Phonix, AZ 85085
PMA NumberP050006
Supplement NumberS109
Date Received01/31/2024
Decision Date04/29/2024
Product Code MLV 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a change to the flush port tubing material that is a component of the Delivery Systems of the GORE® CARDIOFORM ASD Occluder and GORE® CARDIOFORM Septal Occluder
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