FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Alfapump System
PMA: P230044
·
Supplement: S003
·
Decision Feb 18, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Alfapump System
- Trade Name
- alfapump System
- PMA Number
- P230044
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- SDQ
- Generic Name
- alfapump System
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- February 18, 2026
- Date Received
- January 20, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for changes to the cleaning agent used during manufacturing and for a new component supplier.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SDQ | Alfapump System | FDA class 3 | Unknown |