THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAK
FDA premarket approval P860003/S110 · decided 2023-08-10
Approval details
- PMA number
- P860003
- Supplement
- S110
- 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), THERAK
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2023-07-14
- Decision date
- 2023-08-10
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Change to qualify a new core for the drive tube injection mold tool used to manufacture the O-ring sealing gland of the THERAKOS® CELLEX® Procedural Kit, which will also alter the cavity insert for the molding process from P20 Tool Steel to S7 Tool Steel, and improve production readiness.
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