PMA
P970061: SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM
FDA PMA · STENT, CORONARY · Boston Scientific Scimed, Inc.
Key facts
| PMA number | P970061 |
|---|---|
| Trade name | SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM |
| Generic name | STENT, CORONARY |
| Applicant | Boston Scientific Scimed, Inc. |
| Owner/operator | Boston Scientific Corporation |
| Product code | MAF |
| Approval date | Jul 16, 1998 |
| Docket number | 99M-1980 |
| Notice date | Jun 28, 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- Yes Withdrawn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: