THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP),THERAKOS
FDA premarket approval P860003/S107 · decided 2022-05-25
Approval details
- PMA number
- P860003
- Supplement
- S107
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP),THERAKOS
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2022-04-27
- Decision date
- 2022-05-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Qualification of a mold tool with a material change for the core insert. The change is being made for improving production readiness.
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