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) | Registration & Listing | Adverse Events | Recalls | PMA | 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.
 
Trade NameLIPOSORBER(R) LA-15 SYSTEM
Classification Namelipoprotein, low density, removal
Generic Nameadsorption column
ApplicantKANEKA PHARMA AMERICA CORP.
PMA NumberP910018
Supplement NumberS006
Date Received08/07/2000
Decision Date08/21/2000
Product Code
MMY[ Registered Establishments with MMY ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the sterilization process equipment for the plasmapheresis(r) lt-ma2 tubing system that is used with the liposorber(r) la-15 system.
-
-