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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
ApplicantLeica Biosystems
36 Cherry Hill Drive
Danvers, MA 01923
PMA NumberP090015
Supplement NumberS010
Date Received12/13/2019
Decision Date01/02/2020
Product Code MVC 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Addition of an item to the list of 'equipment required but not supplied.
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