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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
Generic NameProstrate cancer genes nucleic acid amplification test system
ApplicantGen-Probe Incorporated
10210 Genetic Center Dr.
San Diedgo, CA 92121
PMA NumberP100033
Supplement NumberS002
Date Received12/22/2014
Decision Date01/21/2015
Withdrawal Date04/12/2023
Product Code OYM 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MANUFACTURING SCALE UP OF THE SELECTION REAGENT USED IN THE PROGENSA PCA3 ASSAY.
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