FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
PMA: P820033
·
Decision Jul 5, 1983
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
- Trade Name
- PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR
- PMA Number
- P820033
- 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
- Decision Code
- APPR
- Decision Date
- July 5, 1983
- Date Received
- May 26, 1982
- Expedited Review
- N
- Docket Number
- 83M-0236
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 |