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. |
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Device | GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST |
Applicant | GEN-PROBE, INC. 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121 |
PMA Number | P940034 |
Supplement Number | S012 |
Date Received | 03/02/2001 |
Decision Date | 08/30/2001 |
Reclassified Date
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06/23/2014 |
Advisory Committee |
Microbiology |
Supplement Type | Normal 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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