PMA P860003S025

Device: THERAKOS UVAR(R) PHOTOPHORESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S025
Product code: LNR
Decision date: 1996-10-03
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order 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 OF THE CYCLE; AND 4) THE USE OF ONE THERMOCOUPLE IN EACH PALLET TO MONITOR PRODUCT TEMPERATURE DURING ROUTINE STERILIZATION

Current openFDA PMA Record#

Device: THERAKOS UVAR(R) PHOTOPHORESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S025
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 1996-10-03
Decision code: APPR
Date received: 1995-02-09
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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 OF THE CYCLE; AND 4) THE USE OF ONE THERMOCOUPLE IN EACH PALLET TO MONITOR PRODUCT TEMPERATURE DURING ROUTINE STERILIZATION