PMA P230044S002
- Device
- alfapump System
- Applicant
- Sequana Medical NV
- PMA number
- P230044
- Supplement
- S002
- Product code
- SDQ
- Decision date
- 2025-12-19
- Classification
- Gastroenterology, Urology
- Generic name
- alfapump System
- Approval order statement
- approval for a new mold release agent
Current openFDA PMA Record#
- Device
- alfapump System
- Applicant
- Sequana Medical NV
- PMA number
- P230044
- Supplement
- S002
- Product code
- SDQ
- Generic name
- alfapump System
- Decision date
- 2025-12-19
- Decision code
- APPR
- Date received
- 2025-09-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for a new mold release agent