HDE supplement
H060001 S023: CODMAN ENTERPRISE & ENTERPRISE 2 Vascular Reconstruction Devices and Delivery System
FDA HDE supplement · 30-day notice · Medos International, SARL
Key facts
| Original HDE | H060001 |
|---|---|
| Supplement number | S023 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | CODMAN ENTERPRISE & ENTERPRISE 2 Vascular Reconstruction Devices and Delivery System |
| Generic name | Intracranial neurovascular stent |
| Applicant | Medos International, SARL |
| Product code | NJE |
| Received date | Dec 26, 2018 |
| Decision date | Jan 25, 2019 |
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: