Therakos Cellex Photopheresis System
FDA premarket approval P860003/S093 · decided 2018-01-28
Approval details
- PMA number
- P860003
- Supplement
- S093
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Therakos Cellex Photopheresis System
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2017-07-10
- Decision date
- 2018-01-28
- Days to decision
- 202 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Approval for manufacturing site located at Harmac Medical Products Limited , I.D.A Industrial EstateCastlerea Roscommon, Ireland for the manufacture and finished product release testing for CELLEX Procedural Kits ; Synergy Health Ireland Ltd , IDA Industrial Estate , Tullamore, Offaly, Ireleand for the sterilization of CELLEX Procedural Kits; and Synergy Health (Steris), Thorne, UK Ltd , Alpha Court Capitol Park, Thorne, South Yorkshire DN8 5TZ, United Kingdom, as the alternate sterilization loc
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.