• 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.
 
DevicePATH VYSION HER-2 DNA PROBE KIT ASSAY
Classification Namesystem, test, her-2/neu, nucleic acid or serum
Generic Namesystem, test, her-2/neu, nucleic acid or serum
Applicant
ABBOTT MOLECULAR, INC.
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP980024
Supplement NumberS007
Date Received06/14/2012
Decision Date12/20/2012
Product Code
MVD[ Registered Establishments with MVD ]
Advisory Committee Pathology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE MANUFACTURING CHANGE TO COMPONENTS OF THE PROBECHEK HER-2/NEU CUTOFF CONTROL SLIDES USED IN THE PATHVYSION HER-2 DNA PROBE KIT. THE CHANGE INCLUDED CREATION OF A NEW MASTER CELL BANK AND A NEW WORKING CELL BANK FROM SEED STOCK OF HS578T CELLS, USED IN THE MANUFACTURE OF THE PROBECHEK HER-2/NEU CUTOFFCONTROL SLIDES.
-
-