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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.
 
DeviceHERCEPTEST
Generic NameSYSTEM, TEST, HER-2/NEU, IHC
ApplicantAgilent Technologies Singapore (International) Pte , Ltd.
# 1 Yishun Ave. 7
Singapore 768923
PMA NumberP980018
Supplement NumberS008
Date Received02/12/2010
Decision Date03/08/2010
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  
CHANGE IN THE MANUFACTURING FILLING PROCESS TO INCREASE THE REAGENT FILL VOLUME TO ADDRESS SHORTAGE CONCERNS.
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