PMA
P130020: SENOCLAIRE
FDA PMA · Digital breast tomosynthesis · GE Healthcare
Key facts
| PMA number | P130020 |
|---|---|
| Trade name | SENOCLAIRE |
| Generic name | Digital breast tomosynthesis |
| Applicant | GE Healthcare |
| Owner/operator | GE HealthCare Technologies Inc. |
| Product code | OTE |
| Approval date | Aug 26, 2014 |
| Docket number | 14M-1279 |
| Notice date | Sep 2, 2014 |
| Establishment registration | 2126677 |
| FEI number | 2126677 |
At a glance
- 1–9 Supplements
- Nov 21, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: