HDE
H130005: LVIS INTRALUMINAL SUPPORT DEVICE
FDA Humanitarian Device Exemption · Micro Vention, Inc.
Key facts
| HDE number | H130005 |
|---|---|
| Trade name | LVIS INTRALUMINAL SUPPORT DEVICE |
| Generic name | Intracranial neurovascular stent |
| Applicant | Micro Vention, Inc. |
| Product code | NJE |
| Approval date | Jul 25, 2014 |
At a glance
- 1–9 Supplements
- May 10, 2017 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 10–99 MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: