UVAR XTS PHOTOPHERESIS SYSTEM
FDA premarket approval P860003/S040 · decided 2002-04-12
Approval details
- PMA number
- P860003
- Supplement
- S040
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- UVAR XTS PHOTOPHERESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2002-03-15
- Decision date
- 2002-04-12
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR A LABELING CHANGE (INCLUSION OF AN ADDITIONAL WARNING) TO ADDRESS THE POTENTIAL FOR THE DEVELOPMENT OF HYPOVOLEMIA AND HYPOTENSION DURING PHOTOPHERESIS TREATMENTS IN PATIENTS WITH ELEVATED TRIGLYCERIDE LEVELS (HYPERLIPIDEMIA), SUCH AS PATIENTS RECEIVING CERTAIN CUTANEOUS T-CELL LYMPHOMA DRUGS, LIKE TARGRETIN. (BEXAROTENE).
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