Product code
NJE: Intracranial neurovascular stent
FDA product code · HDE · Neurology
Key facts
| Product code | NJE |
|---|---|
| Device | Intracranial neurovascular stent |
| Device class | HDE |
| Review panel | Neurology |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | An intracranial neurovascular stent is a tubular device placed in the blood vessel of the intracranial cavity to treat a vascular abnormality. It differs from other stents in that it is intended for intracranial use. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- 1–9 HDE approvals
- 100–999 UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database