• 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.
 
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 NumberS021
Date Received07/29/2016
Decision Date10/14/2016
Product Code
MMY[ Registered Establishments with MMY ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the instructions for use, operator's manual, and the patient guide for the LIPOSORBER® LA-15 System for familial hypercholesterolemia and integration of instructions for use for the LIPOSORBER® LA-15 System for familial hypercholesterolemia and focal segmental glomerulosclerosis.
-
-