PMA supplement
P770010 S002: GONODECTEN
FDA PMA supplement · Mediserve International, Inc.
Key facts
| Original PMA | P770010 |
|---|---|
| Supplement number | S002 |
| Trade name | GONODECTEN |
| Generic name | TEST REAGENTS, NEISSERIA GONORRHOEAE BIOCHEMICAL |
| Applicant | Mediserve International, Inc. |
| Product code | LTS |
| Received date | Oct 14, 1981 |
| Decision date | Nov 19, 1981 |
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: