• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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 LA-15 SYSTEM
Classification Namelipoprotein, low density, removal
Generic Nameadsorption column
ApplicantKANEKA PHARMA AMERICA CORP.
PMA NumberP910018
Supplement NumberS001
Date Received11/02/1998
Decision Date10/29/1999
Product Code
MMY[ Registered Establishments with MMY ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes: 1) replacing the membrane filter unit (mfu) located in the liposorber la-15 adsorption column, with the cardioplegia supor-1220 filter, which is bonded to the extracoporeal blood tubing system, lt-ma2; 2) removing the maintenance unit and adding a clamp valve cover plate to the ma-01 apheresis unit; 3) making nine software changes, most of which are intended to either simplify procedures, ease the display of treatment parameters, or to make the therapy safer for the patients; and, 4) revising the operators' manual to incorporate the revisions associated with the hardware and software changes.
-
-