PMA supplement
N80950 S001: POLYVIOLENE SUTURE
FDA PMA supplement · Look, Inc.
Key facts
| Original PMA | N80950 |
|---|---|
| Supplement number | S001 |
| Trade name | POLYVIOLENE SUTURE |
| Generic name | Suture, nonabsorbable, synthetic, polyester |
| Applicant | Look, Inc. |
| Product code | GAS |
| Received date | Jul 10, 1984 |
| Decision date | Mar 22, 1985 |
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: