PMA supplement
N50485 S016: AMIKACIN ELUTION DISK FOR AUTOBAC
FDA PMA supplement · Normal 180 Day Track · Organon Teknika Corp.
Key facts
| Original PMA | N50485 |
|---|---|
| Supplement number | S016 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Other |
| Trade name | AMIKACIN ELUTION DISK FOR AUTOBAC |
| Generic name | DISCS, ELUTION |
| Applicant | Organon Teknika Corp. |
| Product code | LTX |
| Received date | Jun 12, 1987 |
| Decision date | Aug 10, 1987 |
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: