• 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 NamePATHWAY ANTI-HER 2INEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
Classification Namesystem, test, her-2/neu, ihc
Generic Namemouse monoclonal antibody for aid in the detection of c-eerbb-2 antigen in histological tissue section
ApplicantVENTANA MEDICAL SYSTEMS, INC.
PMA NumberP990081
Supplement NumberS008
Date Received10/21/2010
Decision Date11/17/2010
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Pathology
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in quality controls to ensure the safety in the use of the device by: 1) adding a test to ensure appropriate stain intensity of the primary antibody at the bulk manufacturing stages; and 2) adding a quality control testing steps at the raw material production and bulk manufacturing stages.
-
-