PMA
P970033: T-SCAN 2000
FDA PMA · Imager, breast, electrical impedance · Mirabel Medical Systems, Inc.
Key facts
| PMA number | P970033 |
|---|---|
| Trade name | T-SCAN 2000 |
| Generic name | Imager, breast, electrical impedance |
| Applicant | Mirabel Medical Systems, Inc. |
| Product code | NCL |
| Approval date | Apr 16, 1999 |
| Docket number | 99M-1073 |
| FEI number | 3004998923 |
At a glance
- 1–9 Supplements
- May 3, 2000 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- No Withdrawn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: