PMA supplement
N83038 S016: PLAIN GUT STERILE ABSORBABLE SUTURES
FDA PMA supplement · Davis & Geck, Inc.
Key facts
| Original PMA | N83038 |
|---|---|
| Supplement number | S016 |
| Trade name | PLAIN GUT STERILE ABSORBABLE SUTURES |
| Generic name | Suture, absorbable, natural |
| Applicant | Davis & Geck, Inc. |
| Product code | GAL |
| Received date | Dec 29, 1982 |
| Decision date | Mar 2, 1983 |
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: