UVAR XTS PHOTOPHORESIS SYSTEM
FDA premarket approval P860003/S035 · decided 2000-01-14
Approval details
- PMA number
- P860003
- Supplement
- S035
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UVAR XTS PHOTOPHORESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 1999-12-20
- Decision date
- 2000-01-14
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Approval is for a new material, Codan Polypropylene RE764F/Cawiton, to be used in the body of the drip chamber of the UVAR XTS System's disposable set.
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