THERAKOS CELLEX INSTRUMENT,PHOTOPHERESIS PROCEDURAL KIT,AND LIGHT ASSEMBLY
FDA premarket approval P860003/S074 · decided 2013-08-28
Approval details
- PMA number
- P860003
- Supplement
- S074
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERAKOS CELLEX INSTRUMENT,PHOTOPHERESIS PROCEDURAL KIT,AND LIGHT ASSEMBLY
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2013-06-03
- Decision date
- 2013-08-28
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR A CHANGE IN THE ADHESIVE USED FOR THE LIDSTOCK OF THE CELLEXS PROCEDURAL KIT PACKAGING.
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