PMA
P110010: PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA PMA · Coronary drug-eluting stent · Boston Scientific Corp
Key facts
| PMA number | P110010 |
|---|---|
| Trade name | PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM |
| Generic name | Coronary drug-eluting stent |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | NIQ |
| Approval date | Nov 22, 2011 |
| Docket number | 11M-0865 |
| Notice date | Dec 9, 2011 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 100–999 Supplements
- Jan 14, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: