PMA
P030010: SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA PMA · Full field digital, system, x-ray, mammographic · Siemens Medical Solution
Key facts
| PMA number | P030010 |
|---|---|
| Trade name | SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Generic name | Full field digital, system, x-ray, mammographic |
| Applicant | Siemens Medical Solution |
| Product code | MUE |
| Approval date | Aug 20, 2004 |
| Docket number | 04M-0387 |
| Notice date | Sep 3, 2004 |
At a glance
- 1–9 Supplements
- Nov 5, 2010 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: