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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 NumberS004
Date Received02/02/2017
Decision Date02/15/2017
Product Code MVC 
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Transfer of several items of equipment from one testing laboratory to another laboratory within the same manufacture site. The equipment is used to complete the Quality Control testing of the BOND Oracle HER2 IHC System.
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