PMA
P990039: QUS-2 (TM) CALCANEAL ULTRASONOMETER
FDA PMA · Tester, acoustic, bone quality · Quidel Corp.
Key facts
| PMA number | P990039 |
|---|---|
| Trade name | QUS-2 (TM) CALCANEAL ULTRASONOMETER |
| Generic name | Tester, acoustic, bone quality |
| Applicant | Quidel Corp. |
| Owner/operator | QuidelOrtho Corporation |
| Product code | NAN |
| Approval date | Aug 1, 2000 |
| Docket number | 00M-1437 |
| Notice date | Aug 16, 2000 |
| Establishment registration | 2024674 |
| FEI number | 2024674 |
At a glance
- 1–9 Supplements
- Jun 19, 2003 Latest supplement decision
- Yes Withdrawn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: