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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameprostrate cancer genes nucleic acid amplification test system
ApplicantHOLOGIC, INC.
PMA NumberP100033
Supplement NumberS003
Date Received03/19/2015
Decision Date04/16/2015
Product Code
OYM[ Registered Establishments with OYM ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing scale up of bulk enzyme reconstitution solution (p/n bs0421), by allowing bulking and filling from larger tanks (208l and 303l) and additionally, to extend the bulk hold time from 7 days up to 1 month to allow sufficient time for the solution to be used within manufacturing.