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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.
 
Devicealfapump System
Generic Namealfapump System
ApplicantSequana Medical NV
Kortrijksesteweg 1112
Sint-Denijs-Westrem 9051
PMA NumberP230044
Supplement NumberS003
Date Received01/20/2026
Decision Date02/18/2026
Product Code SDQ 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the cleaning agent used during manufacturing and for a new component supplier.
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