PMA
P970040: ACHILLES EXPRESS ULTRASONOMETER
FDA PMA · Bone sonometer · Ge Lunar Corp.
Key facts
| PMA number | P970040 |
|---|---|
| Trade name | ACHILLES EXPRESS ULTRASONOMETER |
| Generic name | Bone sonometer |
| Applicant | Ge Lunar Corp. |
| Product code | MUA |
| Approval date | Jun 26, 1998 |
| Docket number | 98M-0715 |
| Notice date | Oct 7, 1998 |
At a glance
- 1–9 Supplements
- Jul 30, 2004 Latest supplement decision
- No Withdrawn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: