PMA
P970017: SAHARA CLINICAL BONE SONOMETER
FDA PMA · Bone sonometer · Hologic, Inc.
Key facts
| PMA number | P970017 |
|---|---|
| Trade name | SAHARA CLINICAL BONE SONOMETER |
| Generic name | Bone sonometer |
| Applicant | Hologic, Inc. |
| Owner/operator | HOLOGIC, INC. |
| Product code | MUA |
| Approval date | Mar 12, 1998 |
| Docket number | 98M-0187 |
| Notice date | Apr 16, 1998 |
| Establishment registration | 1222780 |
| FEI number | 1000120743 |
At a glance
- 1–9 Supplements
- Apr 29, 1999 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- No Withdrawn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: