alfapump System
FDA premarket approval P230044/S002 · decided 2025-12-19
Approval details
- PMA number
- P230044
- Supplement
- S002
- 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
- 2025-09-25
- Decision date
- 2025-12-19
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- SDQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Sint-Denijs-Westrem
- Statement
- approval for a new mold release agent
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.