THERAKOS® CELLEX® Photopheresis System Procedural Kit
FDA premarket approval P860003/S113 · decided 2025-06-30
Approval details
- PMA number
- P860003
- Supplement
- S113
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THERAKOS® CELLEX® Photopheresis System Procedural Kit
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2025-06-02
- Decision date
- 2025-06-30
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- This 30-Day Notice is to update the Outer Bowl Cover specification to include a flash specification and to implement a Quality Control inspection process for excess flash at CMO (Harmac) of the THERAKOS® CELLEX® Photopheresis System Procedural Kit from Therakos Development Limited.
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