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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
Devicealfapump System
Generic Namealfapump System
ApplicantSequana Medical NV
Kortrijksesteweg 1112
Sint-Denijs-Westrem 9051
PMA NumberP230044
Date Received12/28/2023
Decision Date12/20/2024
Product Code SDQ 
Docket Number 25M-0050
Notice Date 01/10/2025
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for alfapump System for the indication of: The alfapump System is intended for single patient use only in adult patients with refractory or recurrent ascites due to liver cirrhosis. It is indicated for the removal of excess peritoneal fluid from the peritoneal cavity into the bladder, where it can be eliminated through normal urination.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 
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