PMA
P000022: BESTENT 2 OVER-THE-WIRE (OTW)/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
FDA PMA · STENT, CORONARY · Medtronic Vascular
Key facts
| PMA number | P000022 |
|---|---|
| Trade name | BESTENT 2 OVER-THE-WIRE (OTW)/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM |
| Generic name | STENT, CORONARY |
| Applicant | Medtronic Vascular |
| Owner/operator | Medtronic, Inc. |
| Product code | MAF |
| Approval date | Oct 16, 2000 |
| Docket number | 01M-0039 |
| Notice date | Jan 31, 2001 |
| Establishment registration | 2953200 |
| FEI number | 3001452571 |
At a glance
- 1–9 Supplements
- Oct 2, 2001 Latest supplement decision
- Yes Withdrawn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: