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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST
ApplicantGEN-PROBE, INC.
10210 GENETIC CENTER DR.
SAN DIEGO, CA 92121
PMA NumberP940034
Supplement NumberS012
Date Received03/02/2001
Decision Date08/30/2001
Reclassified Date 06/23/2014
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
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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