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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.
 
DeviceLEICA BOND ORACLE HER2 IHC SYSTEM
Generic Namesystem, test, her-2/neu, ihc
Applicant
Leica Biosystems
36 cherry hill drive
danvers, MA 01923
PMA NumberP090015
Supplement NumberS003
Date Received04/20/2015
Decision Date05/20/2015
Product Code MVC 
Advisory Committee Pathology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR LABELLING CHANGES.
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