THERAKOS CELLEX* PHOTOPHERESIS SYSTEM
FDA premarket approval P860003/S053 · decided 2009-05-27
Approval details
- PMA number
- P860003
- Supplement
- S053
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THERAKOS CELLEX* PHOTOPHERESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2009-04-28
- Decision date
- 2009-05-27
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- CHANGE TO PERFORM FINAL PRODUCT TESTING ON CELLEX PROCEDURAL KITS AT A CONTRACT MANUFACTURER.
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