FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Alfapump System
PMA: P230044
·
Decision Dec 20, 2024
Classifications
1
FEI Numbers
2
Registration Numbers
2
Basic Information
- Device Name
- Alfapump System
- Trade Name
- alfapump System
- PMA Number
- P230044
- Device Class
- FDA Class 3
- Product Code
- SDQ
- Generic Name
- alfapump System
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 20, 2024
- Date Received
- December 28, 2023
- Expedited Review
- N
- Docket Number
- 25M-0050
Advisory Committee Statement
Approval for alfapump System for the indication of: The alfapump System is intended for single patient use only in adult patients with refractory or recurrent ascites due to liver cirrhosis. It is indicated for the removal of excess peritoneal fluid from the peritoneal cavity into the bladder, where it can be eliminated through normal urination.
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 |