UVAR PHOTOPHORESIS SYSTEM
FDA premarket approval P860003/S029 · decided 1998-02-26
Approval details
- PMA number
- P860003
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UVAR PHOTOPHORESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 1997-09-11
- Decision date
- 1998-02-26
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Approval for Griffith Micro Science in Glens Falls, New York, to serve as the contract sterilization facility for th esterilization of the TK001 Photopheresis Procedural Kit, which is validated utilizing a biological indicator system internal to the product.
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