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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 Dr.
Danvers, MA 01923
PMA NumberP090015
Supplement NumberS014
Date Received05/08/2026
Decision Date06/04/2026
Product Code MVC 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a manufacturing QC change
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