PMA
P020040: NIRFLEX PREMOUNTED STENT
FDA PMA · STENT, CORONARY · Medinol, Ltd.
Key facts
| PMA number | P020040 |
|---|---|
| Trade name | NIRFLEX PREMOUNTED STENT |
| Generic name | STENT, CORONARY |
| Applicant | Medinol, Ltd. |
| Owner/operator | MEDINOL LTD. |
| Product code | MAF |
| Approval date | Oct 24, 2003 |
| Docket number | 03M-0524 |
| Notice date | Nov 13, 2003 |
| Establishment registration | 3003084171 |
| FEI number | 3003084171 |
At a glance
- 1–9 Supplements
- May 23, 2008 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- Yes Withdrawn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: