• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameBOND ORACLE HER2 IHC SYSTEM
Classification Namesystem, test, her-2/neu, ihc
ApplicantLEICA BIOSYSTEMS
PMA NumberP090015
Date Received07/22/2009
Decision Date04/18/2012
Product Code
MVC[ Registered Establishments with MVC ]
Docket Number 12M-0390
Notice Date 04/25/2012
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the bond oracle her2 ihc system. This device is indicated for: bond oracle her2 ihc system is a semi-quantitative immunohistochemical (ihc) assay to determine her2 (human epidermal growth factor receptor 2) oncoprotein status in formalin-fixed, parrafin embedded breast cancer tissue processed for histological evaluation following automated staining on the bond-max slide staining instrument. The bond oracle her2 ihc system is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered.
Approval Order Approval Order
Supplements: S001 
-
-