THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAK
FDA premarket approval P860003/S111 · decided 2025-02-27
Approval details
- PMA number
- P860003
- Supplement
- S111
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAK
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2023-12-12
- Decision date
- 2025-02-27
- Days to decision
- 443 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Approval for software and labelling changes proposed for the TherakosCellex Photopheresis System to provide adequate instruction and controls for the use of a new anticoagulant (ACD-A) with the Cellex Photopheresis system and change to the materials of the Therakos Cellex Photopheresis procedural kit to remove the plasticizer di(2-ethylhexyl) phthalate, more commonly known as DEHP.
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