THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT
FDA premarket approval P860003/S083 · decided 2016-04-08
Approval details
- PMA number
- P860003
- Supplement
- S083
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2016-01-12
- Decision date
- 2016-04-08
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Approval for a change in the color scheme of the anticoagulant line from green-striped to orange-striped, and in the color of the anticoagulant spike chamber from white to orange.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.