PMA
P020026: CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER
FDA PMA · Coronary drug-eluting stent · Cordis Corp.
Key facts
| PMA number | P020026 |
|---|---|
| Trade name | CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER |
| Generic name | Coronary drug-eluting stent |
| Applicant | Cordis Corp. |
| Owner/operator | Cordis US Corp. |
| Product code | NIQ |
| Approval date | Apr 24, 2003 |
| Docket number | 03M-0172 |
| Notice date | Sep 8, 2004 |
| Establishment registration | 1016427 |
| FEI number | 1016427 |
At a glance
- 10–99 Supplements
- Oct 10, 2014 Latest supplement decision
- Yes Withdrawn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: