Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | THERAKOS UVAR(R) PHOTOPHORESIS SYSTEM |
Generic Name | System, photopheresis, extracorporeal |
Applicant | Mallinckrodt Pharmaceuticals Ireland Limited College Business & Technology Park Cruiserath Road Blanchardstown D15 T |
PMA Number | P860003 |
Supplement Number | S025 |
Date Received | 02/09/1995 |
Decision Date | 10/03/1996 |
Product Code |
LNR |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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 |
|
|