THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO
FDA premarket approval P860003/S106 · decided 2022-03-11
Approval details
- PMA number
- P860003
- Supplement
- S106
- 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), THERAKO
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2022-02-09
- Decision date
- 2022-03-11
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Moving the moulding production of the Y-Fitting Adapter component from Harmac Buffalo, NY, USA site to Harmac Castlerea, Republic of Ireland site to improve moulding capacity and component supply.
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