PMA
P970026: MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN
FDA PMA · Bone sonometer · Myriad Ultrasound Systems, Ltd.
Key facts
| PMA number | P970026 |
|---|---|
| Trade name | MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN |
| Generic name | Bone sonometer |
| Applicant | Myriad Ultrasound Systems , Ltd. |
| Product code | MUA |
| Approval date | May 29, 1998 |
| Docket number | 98M-0722 |
| Notice date | Sep 9, 1998 |
At a glance
- None Supplements
- May 29, 1998 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- No Withdrawn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: