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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 NumberS005
Date Received06/12/2015
Decision Date07/09/2015
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  
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.
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