PMA
P100023: ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS)
FDA PMA · Coronary drug-eluting stent · Boston Scientific Corp
Key facts
| PMA number | P100023 |
|---|---|
| Trade name | ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS) |
| Generic name | Coronary drug-eluting stent |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | NIQ |
| Approval date | Apr 22, 2011 |
| Docket number | 11M-0342 |
| Notice date | May 12, 2011 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 100–999 Supplements
- Feb 16, 2016 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: