alfapump System
FDA premarket approval P230044 · decided 2024-12-20
Approval details
- PMA number
- P230044
- Trade name
- alfapump System
- Generic name
- alfapump System
- Applicant
- Sequana Medical NV
- Date received
- 2023-12-28
- Decision date
- 2024-12-20
- Days to decision
- 358 days
- Decision code
- APPR
- Product code
- SDQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Sint-Denijs-Westrem
- 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.
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