THERAKOS CELLEX / THERAKOS UVAR XTS PHOTOPHERESIS SYSTEMS
FDA premarket approval P860003/S069 · decided 2013-02-15
Approval details
- PMA number
- P860003
- Supplement
- S069
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THERAKOS CELLEX / THERAKOS UVAR XTS PHOTOPHERESIS SYSTEMS
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2013-01-14
- Decision date
- 2013-02-15
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR LABELING MODIFICATIONS TO INCLUDE A WARNING STATEMENT REGARDING THE USE OF THE DEVICE ON THE SAME DAY AS OTHER PROCEDURES THAT MAY CAUSE SIGNIFICANT FLUID CHANGES IN A PATIENT.
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