PMA supplement
P140011 S005: Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option
FDA PMA supplement · Real-Time Process · Siemens Medical Solutions USA, Inc.
Key facts
| Original PMA | P140011 |
|---|---|
| Supplement number | S005 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option |
| Generic name | Digital breast tomosynthesis |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product code | OTE |
| Received date | Aug 21, 2017 |
| Decision date | Sep 29, 2017 |
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: