THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERA
FDA premarket approval P860003/S105 · decided 2021-10-01
Approval details
- PMA number
- P860003
- Supplement
- S105
- 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), THERA
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2021-09-03
- Decision date
- 2021-10-01
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Moving production of the Ballast Monitor PCBA and Bracket Assembly from EAS to new supplier Saline Lectronics.
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