Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceTHERAKOS UVAR(R) PHOTOPHORESIS SYSTEM
Generic NameSystem, photopheresis, extracorporeal
ApplicantMallinckrodt Pharmaceuticals Ireland Limited
College Business & Technology Park
Cruiserath Road
Blanchardstown D15 T
PMA NumberP860003
Supplement NumberS025
Date Received02/09/1995
Decision Date10/03/1996
Product Code LNR 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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
-
-