PMA
P980001: NIR ON TM RANGER TM PREMOUNTED STENT SYSTEM
FDA PMA · STENT, CORONARY · Boston Scientific Corp
Key facts
| PMA number | P980001 |
|---|---|
| Trade name | NIR ON TM RANGER TM PREMOUNTED STENT SYSTEM |
| Generic name | STENT, CORONARY |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | MAF |
| Approval date | Aug 11, 1998 |
| Docket number | 99M-1696 |
| Notice date | Jun 9, 1999 |
| Establishment registration | 3005099803 |
| FEI number | 3005099803 |
At a glance
- 10–99 Supplements
- Jul 25, 2003 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- Yes Withdrawn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: