• 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.
 
DeviceLIPOSORBER(R) LA-15 SYSTEM
Classification Namelipoprotein, low density, removal
Generic Namelipoprotein, low density, removal
Applicant
KANEKA PHARMA AMERICA CORP.
546 fifth ave., 21st floor
new york, NY 10036
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 - manufacturer/sterilizer/packager/supplier
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.
-
-