PMA P230044S001

Device
alfapump System
Applicant
Sequana Medical NV
PMA number
P230044
Supplement
S001
Product code
SDQ
Decision date
2025-07-09
Classification
Gastroenterology, Urology
Generic name
alfapump System
Approval order statement
Approval for a minor design change to the pin of the battery for the alfapump System.

Current openFDA PMA Record#

Device
alfapump System
Applicant
Sequana Medical NV
PMA number
P230044
Supplement
S001
Product code
SDQ
Generic name
alfapump System
Decision date
2025-07-09
Decision code
APPR
Date received
2025-05-19
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a minor design change to the pin of the battery for the alfapump System.