alfapump System
FDA premarket approval P230044/S001 · decided 2025-07-09
Approval details
- PMA number
- P230044
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- alfapump System
- Generic name
- alfapump System
- Applicant
- Sequana Medical NV
- Date received
- 2025-05-19
- Decision date
- 2025-07-09
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- SDQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Sint-Denijs-Westrem
- Statement
- Approval for a minor design change to the pin of the battery for the alfapump System.
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