PMA supplement
P840041 S006: NOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE
FDA PMA supplement · Special (Immediate Track) · Davis & Geck, Inc.
Key facts
| Original PMA | P840041 |
|---|---|
| Supplement number | S006 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | NOVAFIL(R) AND VASCUFIL(R) POLYBUTESTER MONOFILAMENT NONABSORBABLE SURGICAL SUTURE |
| Generic name | Suture, nonabsorbable, synthetic, polyester |
| Applicant | Davis & Geck, Inc. |
| Product code | GAS |
| Received date | Dec 19, 1995 |
| Decision date | Jan 11, 1996 |
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: