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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameGEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST
ApplicantGEN-PROBE, INC.
PMA NumberP940034
Supplement NumberS012
Date Received03/02/2001
Decision Date08/30/2001
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product 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.
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