AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Premarket Approval P940034 S019

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.

Pre-market Approval Supplement Details

Change in the amplification positive control used for quality control testing.

• Device: AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST
• Classification Name: System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
• Generic Name: System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
• Applicant: GEN-PROBE, INC.
• Date Received: 2012-11-07
• Decision Date: 2012-12-05
• PMA: P940034
• Supplement: S019
• Product Code: MWA
• Advisory Committee: Microbiology
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: GEN-PROBE, INC. 10210 Genetic Center Dr. san Diego, CA 92121

Supplemental Filings

Supplement Number	Date	Supplement Type
P940034		Original Filing
S019	2012-11-07	30-day Notice
S018	2010-03-31	30-day Notice
S017	2006-07-27	135 Review Track For 30-day Notice
S016	2004-09-21	30-day Notice
S015	2004-01-22	30-day Notice
S014
S013	2001-12-18	Special (immediate Track)
S012	2001-03-02	Normal 180 Day Track
S011	2000-10-25	Real-time Process
S010	1999-05-12	30-day Notice
S009	1998-10-19	Special (immediate Track)
S008	1998-09-04	Panel Track
S007	1998-08-17	Normal 180 Day Track
S006	1997-09-15	Normal 180 Day Track
S005	1997-07-02	Normal 180 Day Track
S004	1997-01-24	Normal 180 Day Track
S003	1996-06-17	Normal 180 Day Track
S002	1996-05-22	Special (immediate Track)
S001	1996-02-23	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
15420045500303	P940034	019