THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
FDA premarket approval P860003/S079 · decided 2015-04-16
Approval details
- PMA number
- P860003
- Supplement
- S079
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2015-03-13
- Decision date
- 2015-04-16
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- UPDATE ON POST STERILIZATION AERATION CYCLE TIMES FOR THE THERAKOS CELLEX PHOTOPHERESIS SYSTEMS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.