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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 NumberS010
Date Received05/12/1999
Decision Date05/25/1999
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
30-day notice for the following changes: revised performance specifications for specific materials and the addition of qualified vendors; and implementation of additional in-process qualification procedures for testing oligonucleo tide materials.
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