PMA
P850054: STRKYER KNEE AUGMENTATION GRAFT
FDA PMA · LIGAMENTS AND TENDONS, SYNTHETIC · Meadox Medicals, Div. Boston Scientific Corp.
Key facts
| PMA number | P850054 |
|---|---|
| Trade name | STRKYER KNEE AUGMENTATION GRAFT |
| Generic name | LIGAMENTS AND TENDONS, SYNTHETIC |
| Applicant | Meadox Medicals, Div. Boston Scientific Corp. |
| Owner/operator | Ferry Machine Corporation |
| Product code | LML |
| Approval date | Dec 30, 1988 |
| Docket number | 89M-0043 |
| Notice date | Apr 18, 1989 |
| Establishment registration | 3043543260 |
| FEI number | 3043543260 |
At a glance
- None Supplements
- Dec 30, 1988 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- Yes Withdrawn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: