|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||ACS:180 & ADVIA CENTAUR CPSA IMMUNOASSAYS|
|Classification Name||antigen(complexed),prostate specific,(cpsa)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - specifications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the adjustment of the calibration of the device.