UVAR XTS PHOTOPHERESIS SYSTEM
FDA premarket approval P860003/S034 · decided 1999-11-29
Approval details
- PMA number
- P860003
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UVAR XTS PHOTOPHERESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 1999-11-05
- Decision date
- 1999-11-29
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- The 30-Day Notice requested a change in the sterilization process to place the biological indicator, that is normally placed inside of the treatment kit packaging, in an external challenge device on the outside of the kits.
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