THERAKOS CELLEX PHOTOPHERESIS KIT
FDA premarket approval P860003/S075 · decided 2014-05-09
Approval details
- PMA number
- P860003
- Supplement
- S075
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERAKOS CELLEX PHOTOPHERESIS KIT
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2014-02-10
- Decision date
- 2014-05-09
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR A CHANGE IN THE GEOMETRY OF THE STAND-OFFS FEATURED ON THE INNER LOWER BOWL COVER OF THE CELLEX® PROCEDURAL KIT¿S CENTRIFUGE BOWL
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.