PMA supplement
P940034 S008: GEN-PROBE(R) AMPLIFIED(TM) MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST
FDA PMA supplement · Panel Track · Gen-Probe, Inc.
Key facts
| Original PMA | P940034 |
|---|---|
| Supplement number | S008 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | GEN-PROBE(R) AMPLIFIED(TM) MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST |
| Applicant | Gen-Probe, Inc. |
| Received date | Sep 4, 1998 |
| Decision date | Sep 30, 1999 |
| Docket number | 00M-0578 |
| Notice date | Feb 15, 2000 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: