PMA
P020009: EXPRESS/EXPRESS 2 MR & OTW CORONARY STENT SYSTEMS
FDA PMA · STENT, CORONARY · Boston Scientific Scimed, Inc.
Key facts
| PMA number | P020009 |
|---|---|
| Trade name | EXPRESS/EXPRESS 2 MR & OTW CORONARY STENT SYSTEMS |
| Generic name | STENT, CORONARY |
| Applicant | Boston Scientific Scimed, Inc. |
| Owner/operator | Boston Scientific Corporation |
| Product code | MAF |
| Approval date | Sep 11, 2002 |
| Docket number | 03M-0116 |
| Notice date | Mar 25, 2003 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 100–999 Supplements
- Aug 10, 2016 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: