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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.
 
DevicePROGENSA PCA3 ASSAY
Classification Nameprostrate cancer genes nucleic acid amplification test system
Generic Nameprostrate cancer genes nucleic acid amplification test system
Applicant
GEN-PROBE INCORPORATED
10210 genetic center drive
san diego, CA 92121
PMA NumberP100033
Supplement NumberS002
Date Received12/22/2014
Decision Date01/21/2015
Product Code
OYM[ Registered Establishments with OYM ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
MANUFACTURING SCALE UP OF THE SELECTION REAGENT USED IN THE PROGENSA PCA3 ASSAY.
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