HDE supplement
H130005 S005: LVIS INTRALUMINAL SUPPORT DEVICE
FDA HDE supplement · normal 75 day track · Micro Vention, Inc.
Key facts
| Original HDE | H130005 |
|---|---|
| Supplement number | S005 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | LVIS INTRALUMINAL SUPPORT DEVICE |
| Generic name | Intracranial neurovascular stent |
| Applicant | Micro Vention, Inc. |
| Product code | NJE |
| Received date | Apr 5, 2017 |
| Decision date | May 10, 2017 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: