PMA
P140011: MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION
FDA PMA · Digital breast tomosynthesis · Siemens Medical Solutions USA, Inc.
Key facts
| PMA number | P140011 |
|---|---|
| Trade name | MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION |
| Generic name | Digital breast tomosynthesis |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Owner/operator | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Product code | OTE |
| Approval date | Apr 21, 2015 |
| Docket number | 15M-1460 |
| Notice date | May 18, 2015 |
| Establishment registration | 2240869 |
| FEI number | 2240869 |
At a glance
- 1–9 Supplements
- Jul 1, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: