THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHRESSIS PROCEDURAL KIT (125 ML), CLX, THERAKOS CELLEX LIGHT ASSEMBLY ,
FDA premarket approval P860003/S067 · decided 2012-11-19
Approval details
- PMA number
- P860003
- Supplement
- S067
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHRESSIS PROCEDURAL KIT (125 ML), CLX, THERAKOS CELLEX LIGHT ASSEMBLY ,
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2012-09-27
- Decision date
- 2012-11-19
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR SOME MINOR CHANGES INTENDED TO REDUCE SPECULAR REFLECTION OF THE KT8L SENSOR'S LASER BEAM AND IMPROVE ITS OPTIC PATH (E.G., REMOVAL OF GLASS PORT, REMOVAL OF RESISTOR, AND ADDITION OF GASKET).
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