PMA supplement
P020026 S048: CYPHER SIROLIMUS-ELUTING CORONARY STENT SYSTEM ON THE RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY S
FDA PMA supplement · Normal 180 Day Track No User Fee · Cordis Corp.
Key facts
| Original PMA | P020026 |
|---|---|
| Supplement number | S048 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Other |
| Trade name | CYPHER SIROLIMUS-ELUTING CORONARY STENT SYSTEM ON THE RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY S |
| Generic name | Coronary drug-eluting stent |
| Applicant | Cordis Corp. |
| Product code | NIQ |
| Received date | Dec 21, 2007 |
| Decision date | Oct 9, 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: