UVAR PHOTOPHERESIS SYSTEM
FDA premarket approval P860003/S010 · decided 1988-12-28
Approval details
- PMA number
- P860003
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UVAR PHOTOPHERESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 1988-11-17
- Decision date
- 1988-12-28
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
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