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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 NumberS013
Date Received12/22/2023
Decision Date01/17/2024
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  
for approval to add an alternative supplier to the BOND Oracle HER2 IHC System
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