PMA supplement
P030047 S001: CORDIS PRECISE OTW 5.5 FR AND 6.0 FR NITINOL STENT SYSTEM
FDA PMA supplement · Normal 180 Day Track · Cordis US Corporation
Key facts
| Original PMA | P030047 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | CORDIS PRECISE OTW 5.5 FR AND 6.0 FR NITINOL STENT SYSTEM |
| Generic name | Stent, carotid |
| Applicant | Cordis US Corporation |
| Product code | NIM |
| Received date | Sep 27, 2006 |
| Decision date | Nov 16, 2006 |
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: