UVAR PHOTOPHORESIS SYSTEM
FDA premarket approval P860003/S027 · decided 1996-05-17
Approval details
- PMA number
- P860003
- Supplement
- S027
- 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
- 1995-10-05
- Decision date
- 1996-05-17
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL TO CHANGE THE MANUFACTURING FACILITY FOR THE TPS102 PHOTOCEPTOR COMPONENT OF THE UVAR PHOTOPHERESIS SYSTEM FROM THERAKOS TO HARMAC MEDICAL PRODUCTS AT 2201 BAILEY AVENUE IN BUFFALO, NEW YORK (ESTABLISHMENT REGISTRATION #1317547)
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