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 PROTEIN A IMMUNOADSORPTION COLUMN
Generic NameSeparator, automated, blood cell and plasma, therapeutic
ApplicantFRESENIUS HEMOCARE, INC.
920 WINTER STREET
WALTHAM, MA 02451
PMA NumberP850020
Supplement NumberS020
Date Received07/01/2005
Decision Date08/17/2005
Withdrawal Date 04/14/2008
Product Code LKN 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ETHYLENE OXIDE (EO) STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, INC., WAUKEGAN, ILLINOIS.
-
-