PMA
P080003: SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA PMA · Digital breast tomosynthesis · Hologic, Inc.
Key facts
| PMA number | P080003 |
|---|---|
| Trade name | SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Generic name | Digital breast tomosynthesis |
| Applicant | Hologic, Inc. |
| Owner/operator | HOLOGIC, INC. |
| Product code | OTE |
| Approval date | Feb 11, 2011 |
| Docket number | 11M-0131 |
| Notice date | Mar 9, 2011 |
| Establishment registration | 1222780 |
| FEI number | 1000120743 |
At a glance
- 10–99 Supplements
- Nov 24, 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- No Withdrawn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: