|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||IMX AND AXSYM PSA|
|Classification Name||prostate-specific antigen (psa) for management of prostate cancers|
|Supplement Type|| Special Supplement|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to add a quality control test which will be performed after the reagent pack is packaged.