PMA supplement
P110010 S001: PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA PMA supplement · Panel Track · Boston Scientific Corp
Key facts
| Original PMA | P110010 |
|---|---|
| Supplement number | S001 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM |
| Generic name | Coronary drug-eluting stent |
| Applicant | Boston Scientific Corp |
| Product code | NIQ |
| Received date | Nov 30, 2011 |
| Decision date | Jun 1, 2012 |
| Docket number | 12M-0562 |
| Notice date | Jun 18, 2012 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: