UVAR XTS PHOTOPHERESIS SYSTEM
FDA premarket approval P860003/S032 · decided 1998-09-01
Approval details
- PMA number
- P860003
- Supplement
- S032
- Supplement type
- Real-Time Process
- 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
- 1998-08-26
- Decision date
- 1998-09-01
- Days to decision
- 6 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Approval for a labeling change to include a natural rubber latex caution statement in the labels for the Photopheresis Procedural Kit, the Photoactivation Line, and the Photopheresis Procedural Kit Carton.
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