PMA supplement
P850069 S006: KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE
FDA PMA supplement · Panel Track · 3M Company
Key facts
| Original PMA | P850069 |
|---|---|
| Supplement number | S006 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE |
| Generic name | LIGAMENTS AND TENDONS, SYNTHETIC |
| Applicant | 3M Company |
| Product code | LML |
| Received date | Dec 26, 1989 |
| Decision date | Dec 31, 1992 |
| Docket number | 93M-0018 |
| Notice date | May 3, 1993 |
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: