PMA
P980009: MAGIC WALLSTENT ENDOPROTHESIS
FDA PMA · STENT, CORONARY · Boston Scientific Scimed, Inc.
Key facts
| PMA number | P980009 |
|---|---|
| Trade name | MAGIC WALLSTENT ENDOPROTHESIS |
| Generic name | STENT, CORONARY |
| Applicant | Boston Scientific Scimed, Inc. |
| Owner/operator | Boston Scientific Corporation |
| Product code | MAF |
| Approval date | Sep 29, 1998 |
| Docket number | 99M-2028 |
| Notice date | Jun 24, 1999 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 10–99 Supplements
- Oct 31, 2005 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- Yes Withdrawn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: