PMA supplement
P940034 S012: GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST
FDA PMA supplement · Normal 180 Day Track · Gen-Probe, Inc.
Key facts
| Original PMA | P940034 |
|---|---|
| Supplement number | S012 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Other |
| Trade name | GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST |
| Applicant | Gen-Probe, Inc. |
| Received date | Mar 2, 2001 |
| Decision date | Aug 30, 2001 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: