PMA
P240009: Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection
FDA PMA · Stent, carotid · Contego Medical, Inc.
Key facts
| PMA number | P240009 |
|---|---|
| Trade name | Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection |
| Generic name | Stent, carotid |
| Applicant | Contego Medical, Inc. |
| Owner/operator | Contego Medical, INC |
| Product code | NIM |
| Approval date | Oct 11, 2024 |
| Establishment registration | 3011471056 |
| FEI number | 3011471056 |
At a glance
- 1–9 Supplements
- Jul 29, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: