UVAR PHOTOPHORESIS SYSTEM
FDA premarket approval P860003/S024 · decided 1995-05-18
Approval details
- PMA number
- P860003
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- UVAR PHOTOPHORESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 1994-10-26
- Decision date
- 1995-05-18
- Days to decision
- 204 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
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