HDE supplement
H020002 S028: NEUROFORM EZ 2 STENT SYSTEM & NEUROFORM EZ 3 STENT SYSTEM ACCESSORY KIT
FDA HDE supplement · normal 75 day track · Stryker Neurovascular
Key facts
| Original HDE | H020002 |
|---|---|
| Supplement number | S028 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | NEUROFORM EZ 2 STENT SYSTEM & NEUROFORM EZ 3 STENT SYSTEM ACCESSORY KIT |
| Generic name | Intracranial neurovascular stent |
| Applicant | Stryker Neurovascular |
| Product code | NJE |
| Received date | Mar 18, 2011 |
| Decision date | May 26, 2011 |
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: