PMA supplement
P970033 S001: TS2000
FDA PMA supplement · Normal 180 Day Track · Mirabel Medical Systems, Inc.
Key facts
| Original PMA | P970033 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Trade name | TS2000 |
| Generic name | Imager, breast, electrical impedance |
| Applicant | Mirabel Medical Systems, Inc. |
| Product code | NCL |
| Received date | Jun 23, 1999 |
| Decision date | Nov 15, 1999 |
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: