PMA supplement
N18331 S012: PDS SUTURE (DYED)
FDA PMA supplement · ETHICON, Inc.
Key facts
| Original PMA | N18331 |
|---|---|
| Supplement number | S012 |
| Trade name | PDS SUTURE (DYED) |
| Generic name | Suture, surgical, absorbable, polydioxanone |
| Applicant | ETHICON, Inc. |
| Product code | NEW |
| Received date | Mar 17, 1983 |
| Decision date | Sep 6, 1984 |
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: