FDA PMA
FDA Unclassified
Approved
🇺🇸 United States
Separator, Automated, Blood Cell And Plasma, Therapeutic
PMA: P820032
·
Supplement: S001
·
Decision Dec 5, 1983
Classifications
1
FEI Numbers
19
Registration Numbers
19
Basic Information
- Device Name
- Separator, Automated, Blood Cell And Plasma, Therapeutic
- Trade Name
- PLASMA SEPARATION SYSTEM
- PMA Number
- P820032
- Supplement Number
- S001
- Device Class
- FDA Unclassified
- Product Code
- LKN
- Generic Name
- Separator, automated, blood cell and plasma, therapeutic
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 5, 1983
- Date Received
- November 22, 1983
- Expedited Review
- N
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 |
|---|---|---|---|
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | FDA unclassified | Unknown |