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.
 
DeviceAXSYM FREE PSA (LN 3C20)
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantAbbott Laboratories
100 Abbott Park Rd.
Ap5n-2, Dept. 09vb
Abbott Park, IL 60064
PMA NumberP980007
Supplement NumberS023
Date Received11/02/2011
Decision Date12/22/2011
Product Code MTG 
Advisory Committee Immunology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR RELOCATION OF BULK SOLUTION PREPARATION TO NEW MANUFACTURING SPACES IN A BUILDING LOCATED WITHIN THE SAME MANUFACTURING FACILITIES.
-
-