• 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namesystem, photopheresis, extracorporeal
Generic Namesystem, photopheresis, extracorporeal
440 route 22 east
suite 140
bridgewater, NJ 08807
PMA NumberP860003
Supplement NumberS025
Date Received02/09/1995
Decision Date10/03/1996
Product Code
LNR[ Registered Establishments with LNR ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 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.