UVAR CELLEX PHOTOPHERESIS SYSTEM
FDA premarket approval P860003/S048 · decided 2009-03-20
Approval details
- PMA number
- P860003
- Supplement
- S048
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UVAR CELLEX PHOTOPHERESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2008-06-11
- Decision date
- 2009-03-20
- Days to decision
- 282 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR ENGINEERING AND DESIGN CHANGES TO THE UVAR XTSPHOTOPHERESIS SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMETHERAKOS CELLEX PHOTOPHERESIS SYSTEM, AND IS INDICATED FOR USE IN THE ULTRAVIOLET-A(UVA) IRRADIATION, IN THE PRESENCE OF THE PHOTOACTIVE DRUG 8-METHOXYPSORALEN (8-MOP), OFEXTRACORPOREALLY CIRCULATING LEUKOCYTE-ENRICHED BLOOD, IN THE PALLIATIVE TREATMENT OF THE SKINMANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA (CTCL), IN PERSONS WHO HAVE NOT BEEN RESPONSIVE
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