THERAKOS UVAR XTS Photopheresis System Procedural Kit
FDA premarket approval P860003/S086 · decided 2016-05-05
Approval details
- PMA number
- P860003
- Supplement
- S086
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THERAKOS UVAR XTS Photopheresis System Procedural Kit
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2016-04-08
- Decision date
- 2016-05-05
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- Manufacturing process change to the exterior printing of the Tyvek lid stock for the Therakos UVAR XTS Procedural Kit used with the Therakos UVAR XTS Photopheresis System.
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