PMA
P050025: ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL DELIVERY SYSTEM
FDA PMA · Stent, carotid · Boston Scientific
Key facts
| PMA number | P050025 |
|---|---|
| Trade name | ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL DELIVERY SYSTEM |
| Generic name | Stent, carotid |
| Applicant | Boston Scientific |
| Owner/operator | Boston Scientific Corporation |
| Product code | NIM |
| Approval date | Oct 27, 2006 |
| Docket number | 06M-0459 |
| Notice date | Nov 13, 2006 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 1–9 Supplements
- Apr 9, 2008 Latest supplement decision
- No Withdrawn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: