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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceBOND ORACLE HER2 IHC SYSTEM
Generic Namesystem, test, her-2/neu, ihc
Applicant
Leica Biosystems
36 cherry hill drive
danvers, MA 01923
PMA NumberP090015
Supplement NumberS002
Date Received11/28/2014
Decision Date02/13/2015
Product Code MVC 
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR INTRODUCTION OF BOND VERSION 5.1 SOFTWARE FOR USE ONTHE BOND ORACLE HER2 IHC SYSTEM.
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