THERAKOS CELLEX PHOTOPHERESIS SYSTEM
FDA premarket approval P860003/S057 · decided 2011-07-29
Approval details
- PMA number
- P860003
- Supplement
- S057
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERAKOS CELLEX PHOTOPHERESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2011-01-31
- Decision date
- 2011-07-29
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR SOFTWARE CHANGES TO THE THERAKOS CELLEX PHOTOPHERESIS SYSTEM.
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