PMA P940034S012

Device: GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST
Applicant: Gen-Probe, Inc.
PMA number: P940034
Supplement: S012
Decision date: 2001-08-30
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.

Current openFDA PMA Record#

Device: GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST
Applicant: Gen-Probe, Inc.
PMA number: P940034
Supplement: S012
Decision date: 2001-08-30
Decision code: APPR
Date received: 2001-03-02
Supplement type: Normal 180 Day Track
Supplement reason: Other
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.