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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 Oracel HER2 IHC System
Generic Namesystem, test, her-2/neu, ihc
Applicant
Leica Biosystems
36 cherry hill drive
danvers, MA 01923
PMA NumberP090015
Supplement NumberS008
Date Received07/24/2019
Decision Date09/12/2019
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 
Adding a second supplier for a reagent.
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