|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||GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST|
|Supplement Type||normal 180 day track|
|Supplement Reason|| other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the package insert in lieu of a post-marketing study. The changes include addition of interpretive criteria from the center for disease control and prevention's july 7, 2000, mmwr "update: nucleic acid amplification test for tuberculosis" and the change of a precaution statement concerning negative test results to a warning statement. These changes will be provided in a technical bulletin that will accompany the package insert for the next 4-6 months until the next printing of the package insert.