System, Photopheresis, Extracorporeal
Basic Information
- Device Name
- System, Photopheresis, Extracorporeal
- Trade Name
- UVAR XTS PHOTOPHERESIS SYSTEM
- PMA Number
- P860003
- Supplement Number
- S031
- 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
- August 10, 1999
- Date Received
- August 5, 1998
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for engineering changes to the UVAR(R) Photopheresis System including the following: 1) Replacing the obsolete Haemotronics centrifuge assembly with the current generation Haemotronics centrifuge assembly that includes an optical detector; 2) Replacing the electronic roller pumps and mechanical clamps with a pneumatically-driven fluid management system, including the cassette, fluid logic module and fluid logic controller; 3) Modifying the Photoceptor(R) photoactivation chamber; 4) Redesigning the treatment kit; and 5) Redesigning the user interface and system software. The device is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug methoxsalen (8-methoxypsoralen or 8-MOP), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other therapy.
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 |