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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 NumberS006
Date Received10/26/2018
Decision Date01/23/2019
Product Code MVC 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for replacement of BOND-MAX Slide Staining Assembly (SSA) Printed Wiring Assembly (PWA) and BOND software update from version 5.1 to 6.0.
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