• 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 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 NumberS012
Date Received09/08/2006
Decision Date03/31/2009
Product Code
MMY[ Registered Establishments with MMY ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the liposorber la-15 system using the ma-03 apheresis machine and the blood tubing systems; nk-m3r and nk-m1r.
-
-