PMA
P030009: DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS
FDA PMA · STENT, CORONARY · Medtronic, Ireland
Key facts
| PMA number | P030009 |
|---|---|
| Trade name | DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS |
| Generic name | STENT, CORONARY |
| Applicant | Medtronic, Ireland |
| Owner/operator | Medtronic, Inc. |
| Product code | MAF |
| Approval date | Oct 1, 2003 |
| Docket number | 03M-0490 |
| Notice date | Oct 28, 2003 |
| Establishment registration | 9612164 |
| FEI number | 3002806434 |
At a glance
- 100–999 Supplements
- Jul 15, 2022 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: