|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 |
Manufacturing scale up of bulk enzyme reconstitution solution (p/n bs0421), by allowing bulking and filling from larger tanks (208l and 303l) and additionally, to extend the bulk hold time from 7 days up to 1 month to allow sufficient time for the solution to be used within manufacturing.