THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
FDA premarket approval P860003/S065 · decided 2012-03-02
Approval details
- PMA number
- P860003
- Supplement
- S065
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2012-02-01
- Decision date
- 2012-03-02
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR A TECHNICAL BULLETIN (TECHNICAL BULLETIN XTS #1) THAT WILL BE SENT OUT TO USERS OF THE UVAR XTS PHOTOPHERESIS SYSTEM.
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