PMA supplement
P840041 S001: NOVAFIL(TM)
FDA PMA supplement · Normal 180 Day Track · Davis & Geck, Inc.
Key facts
| Original PMA | P840041 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Other |
| Trade name | NOVAFIL(TM) |
| Generic name | Suture, nonabsorbable, synthetic, polyester |
| Applicant | Davis & Geck, Inc. |
| Product code | GAS |
| Received date | Nov 4, 1986 |
| Decision date | Jan 13, 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: