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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 NumberS005
Date Received06/12/2015
Decision Date07/09/2015
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 
Extension of the pre-cleaning and post-cleaning hold times for automated cleaning of stainless steel tanks used in the manufacture of the selection reagent for the progensa pca3 assay. In addition, a manual cleaning process option is added for the stainless steel tanks as a backup method.