THERAKOS CELLEX PHOTOPHERESIS SYSTEM
FDA premarket approval P860003/S070 · decided 2013-02-19
Approval details
- PMA number
- P860003
- Supplement
- S070
- 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
- 2013-01-24
- Decision date
- 2013-02-19
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- MANUFACTURING PROCESS CHANGE TO APPLY A CURRENTLY USED UV CURABLE ADHESIVE IN AN ADDITIONAL LOCATION WITHIN THE CELLEX PHOTOPHERESIS PROCEDURAL KIT.
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