FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
PMA: P850020
·
Decision Dec 23, 1987
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
- Trade Name
- PROSORBA(TM) COLUMN
- PMA Number
- P850020
- Device Class
- FDA Class 3
- Product Code
- MDP
- Generic Name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- December 23, 1987
- Date Received
- April 2, 1985
- Expedited Review
- N
- Docket Number
- 88M-0019
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 |
|---|---|---|---|
| MDP | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma | FDA class 3 | Unknown |