FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Photopheresis, Extracorporeal
PMA: P860003
·
Supplement: S001
·
Decision May 15, 1987
Classifications
1
FEI Numbers
11
Registration Numbers
11
Basic Information
- Device Name
- System, Photopheresis, Extracorporeal
- Trade Name
- UVAR PHOTOPHERESIS SYSTEM
- PMA Number
- P860003
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- LNR
- Generic Name
- System, photopheresis, extracorporeal
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 15, 1987
- Date Received
- April 7, 1987
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- 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 |
|---|---|---|---|
| LNR | System, Photopheresis, Extracorporeal | FDA class 3 | Unknown |