PMA
P850069: KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE
FDA PMA · LIGAMENTS AND TENDONS, SYNTHETIC · 3M Company
Key facts
| PMA number | P850069 |
|---|---|
| Trade name | KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE |
| Generic name | LIGAMENTS AND TENDONS, SYNTHETIC |
| Applicant | 3M Company |
| Owner/operator | 3M COMPANY |
| Product code | LML |
| Approval date | May 7, 1987 |
| Docket number | 87M-0173 |
| Notice date | Jun 16, 1987 |
| Establishment registration | 2110898 |
| FEI number | 2110898 |
At a glance
- 10–99 Supplements
- Nov 28, 1994 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: