THERAKOS® CELLEX® Photopheresis System (CELLEX), THERAKOS® CELLEX® Photopheresis Procedural Kit (CLXUSA and CLXECP), THE
FDA premarket approval P860003/S112 · decided 2025-11-21
Approval details
- PMA number
- P860003
- Supplement
- S112
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERAKOS® CELLEX® Photopheresis System (CELLEX), THERAKOS® CELLEX® Photopheresis Procedural Kit (CLXUSA and CLXECP), THE
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2025-03-24
- Decision date
- 2025-11-21
- Days to decision
- 242 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Approval for manufacturing changes to the blood and air filter component of the pump tubing organizer in the THERAKOS® CELLEX® Procedural Kit wherein the raw material supplier is changed, and the washing line equipment is updated.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.