PMA supplement
P060033 S001: ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM OVER-THE-WIRE (OTW) & RAPID EXCHANGE (RX) & MULTI EXCHANGE II
FDA PMA supplement · Normal 180 Day Track · Medtronic, Inc.
Key facts
| Original PMA | P060033 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM OVER-THE-WIRE (OTW) & RAPID EXCHANGE (RX) & MULTI EXCHANGE II |
| Generic name | Coronary drug-eluting stent |
| Applicant | Medtronic, Inc. |
| Product code | NIQ |
| Received date | Feb 22, 2008 |
| Decision date | Oct 2, 2008 |
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: