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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 NumberS006
Date Received09/02/2015
Decision Date09/24/2015
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 
Change in supplier for the magnetic particles (ch0206) used in the manufacture of the progensa pca3 assay from thermo fisher scientific to ge healthcare.