|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.|
|Trade Name||PROGENSA PCA3 ASSAY|
|Classification Name||prostrate cancer genes nucleic acid amplification test system|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|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.