PMA P230044
- Device
- alfapump System
- Applicant
- Sequana Medical NV
- Product code
- SDQ
- Decision date
- 2026-05-05
- Generic name
- alfapump System
- Approval order statement
- Change to supplier facility location for PCB coating process
Current openFDA PMA Record#
- Device
- alfapump System
- Applicant
- Sequana Medical NV
- PMA number
- P230044
- Supplement
- S005
- Product code
- SDQ
- Generic name
- alfapump System
- Decision date
- 2026-05-05
- Decision code
- OK30
- Date received
- 2026-04-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to supplier facility location for PCB coating process