|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||ABBOTT AXSYM/TOTAL PSA|
|Classification Name||prostate-specific antigen (psa) for management of prostate cancers|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at abbott health products, inc. , barceloneta, puerto rico.