THERAKOS UVAR XTS INSTRUMENT, THERAKOS UVAR XTS PROCEDURAL KIT (125 ML), THERAKOS UVAR XTS PORCEDURAL KIT (225 ML), THEA
FDA premarket approval P860003/S066 · decided 2012-11-09
Approval details
- PMA number
- P860003
- Supplement
- S066
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERAKOS UVAR XTS INSTRUMENT, THERAKOS UVAR XTS PROCEDURAL KIT (125 ML), THERAKOS UVAR XTS PORCEDURAL KIT (225 ML), THEA
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2012-09-10
- Decision date
- 2012-11-09
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR THE ADDITION OF 8 RIBS TO THE NECK OF THE CENTRIFUGE BOWLS USED IN THE DEVICE AND FOR THE ACCOMPANYING PACKAGING CHANGES.
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