HDE supplement
H020002 S046: NEUROFORM ATLAS STENT SYSTEM
FDA HDE supplement · normal 75 day track · Stryker Neurovascular
Key facts
| Original HDE | H020002 |
|---|---|
| Supplement number | S046 |
| Supplement type | normal 75 day track |
| Reason for the supplement | change design/components/specifications/material |
| Trade name | NEUROFORM ATLAS STENT SYSTEM |
| Generic name | Intracranial neurovascular stent |
| Applicant | Stryker Neurovascular |
| Product code | NJE |
| Received date | Jul 1, 2015 |
| Decision date | Nov 2, 2017 |
At a glance
- Yes 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: