HDE supplement
H060001 S025: ENTERPRISE™ and ENTERPRISE™ 2 Vascular Reconstruction Device and Delivery Systems
FDA HDE supplement · normal 75 day track · Medos International, SARL
Key facts
| Original HDE | H060001 |
|---|---|
| Supplement number | S025 |
| Supplement type | normal 75 day track |
| Reason for the supplement | location change - manufacturer/sterilizer/packager/supplier |
| Trade name | ENTERPRISE™ and ENTERPRISE™ 2 Vascular Reconstruction Device and Delivery Systems |
| Generic name | Intracranial neurovascular stent |
| Applicant | Medos International, SARL |
| Product code | NJE |
| Received date | Nov 23, 2022 |
| Decision date | Feb 6, 2023 |
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: