UVAR PHOTOPHORESIS SYSTEM
FDA premarket approval P860003/S028 · decided 1997-03-25
Approval details
- PMA number
- P860003
- Supplement
- S028
- Trade name
- UVAR PHOTOPHORESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 1997-01-30
- Decision date
- 1997-03-25
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR THE USE OF EXTERNAL BIOLOGICAL INDICATORS TO MONITOR THE STERILIZATIN CYCLES FOR THE PHOTOPHERESIS TPS101 BLOOD TUBING SET, TPS102 PHOTOCEPTOR(R), AND A COMMERCIALLY AVAILABLE BLOOD CENTRIFUGE BOWL.
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