HDE supplement
H160002 S004: PulseRider Aneurysm Neck Reconstruction Device
FDA HDE supplement · normal 75 day track · Medos International, SARL
Key facts
| Original HDE | H160002 |
|---|---|
| Supplement number | S004 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | PulseRider Aneurysm Neck Reconstruction Device |
| Generic name | Intracranial neurovascular stent |
| Applicant | Medos International, SARL |
| Product code | NJE |
| Received date | Sep 12, 2018 |
| Decision date | Mar 25, 2020 |
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: