PMA
P010058: OSTEOSPACE
FDA PMA · Bone sonometer · Medilink
Key facts
| PMA number | P010058 |
|---|---|
| Trade name | OSTEOSPACE |
| Generic name | Bone sonometer |
| Applicant | Medilink |
| Product code | MUA |
| Approval date | Mar 15, 2004 |
| Docket number | 05M-0024 |
| Notice date | Jan 21, 2005 |
At a glance
- None Supplements
- Mar 15, 2004 Latest supplement decision
- No Withdrawn
- Yes 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: