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) | 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.
 
DevicePROSORBA COLUMN
Generic NameSeparator for therapeutic purposes, membrane automated blood cell/plasma
ApplicantFRESENIUS HEMOCARE, INC.
920 WINTER STREET
WALTHAM, MA 02451
PMA NumberP850020
Supplement NumberS023
Date Received04/14/2006
Decision Date05/11/2006
Withdrawal Date 04/14/2008
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A LABELING CHANGE TO INCLUDE INFORMATION ON THE USE OF THE COBE SPECTRA APHERESIS SYSTEM AND THE FRESENIUS AS104 SYSTEM IN CONJUNCTION WITH THE PROSORBA COLUMN.
-
-