UVAR XTS PHOTOPHERESIS SYSTEM
FDA premarket approval P860003/S044 · decided 2006-07-14
Approval details
- PMA number
- P860003
- Supplement
- S044
- 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
- 2006-06-14
- Decision date
- 2006-07-14
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR A LABELING CHANGE TO INCLUDE INFORMATION ON EXTRACORPOREAL BLOOD VOLUME MANAGEMENT AND THE IMPORTANCE OF TESTING PATIENTS' HEMATOCRIT VALUES.
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