Therakos CELLEX Photopheresis System
FDA premarket approval P860003/S102 · decided 2020-07-31
Approval details
- PMA number
- P860003
- Supplement
- S102
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Therakos CELLEX Photopheresis System
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2020-02-03
- Decision date
- 2020-07-31
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Approval for software Version 5.4 and for hardware modifications to the CELLEX® Photopheresis System, including changes to the servo drive electrical isolation hardware and to the Ballast Monitor and Lamp Rear printed circuit board assemblies.
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