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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 Drive
San Diego, CA 92121
PMA NumberP100033
Supplement NumberS003
Date Received03/19/2015
Decision Date04/16/2015
Withdrawal Date 04/12/2023
Product Code OYM 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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, TOEXTEND THE BULK HOLD TIME FROM 7 DAYS UP TO 1 MONTH TO ALLOW SUFFICIENT TIME FOR THE SOLUTION TO BE USED WITHIN MANUFACTURING.
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