THERAKOS UVAR(R) PHOTOPHORESIS SYSTEM
FDA premarket approval P860003/S025 · decided 1996-10-03
Approval details
- PMA number
- P860003
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THERAKOS UVAR(R) PHOTOPHORESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 1995-02-09
- Decision date
- 1996-10-03
- Days to decision
- 602 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR PACKAGING THE THREE DISPOSABLE TREATMENT COMPONENTS (TPS101 BLOOD TUBINT SET, TPS102 PHOTOCEPTOR, AND A COMMERCIALLY AVAILABLE BLOOD CENTRIFUGE BOWL) INTO A SINGEL PROCEDURAL KIT PRIOR TO STERILIZATION; 2) PACKAGING THREE PROCEDURAL KITS TOGETHER IN A SINGLE OVERSHIPPER CARTON; 3) CHANGING THE STERILIZATION CYCLE TO OE WHICH PROVIDES FOR ALONGER EXPOSURE TIME, HIGHER CONCENTRATIONS OF ETHYLENE OXIDE, AND ALLOWS FOR A COOLER PRODUCT TEMPERATURE AT THE BEGINNING OF THE EXPOSURE PHASE
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