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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
Classification Namesystem, test, her-2/neu, ihc
Generic Namesystem, test, her-2/neu, ihc
Applicant
Leica Biosystems
36 cherry hill drive
danvers, MA 01923
PMA NumberP090015
Supplement NumberS001
Date Received07/26/2013
Decision Date02/11/2014
Product Code
MVC[ Registered Establishments with MVC ]
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE MANUFACTURING CHANGES TO THE BOND-MAX SOFTWARE, INSTRUMENT STYLING AND USABILITY, THE REAGENT AND BOND-MAX INSTRUMENT MANUFACTURING PROCESSES, AND ASSOCIATED LABELING CHANGES.
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