UVAR PHOTOPHERESIS SYSTEM
FDA premarket approval P860003/S036 · decided 2000-11-22
Approval details
- PMA number
- P860003
- Supplement
- S036
- 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
- 2000-05-25
- Decision date
- 2000-11-22
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT HARMAC MEDICAL PRODUCTS, CHEEKTOWAGA, NEW YORK.
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