PMA supplement
P140011 S007: MAMMOMAT Revelation with Tomosynthesis Option System
FDA PMA supplement · Normal 180 Day Track · Siemens Medical Solutions USA, Inc.
Key facts
| Original PMA | P140011 |
|---|---|
| Supplement number | S007 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MAMMOMAT Revelation with Tomosynthesis Option System |
| Generic name | Digital breast tomosynthesis |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product code | OTE |
| Received date | Jan 29, 2020 |
| Decision date | Aug 21, 2020 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: