HDE supplement
H050001 S090: Gateway PTA Balloon Catheter
FDA HDE supplement · 30-day notice · STRYKER CORP.
Key facts
| Original HDE | H050001 |
|---|---|
| Supplement number | S090 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | Gateway PTA Balloon Catheter |
| Generic name | Intracranial neurovascular stent |
| Applicant | STRYKER CORP. |
| Product code | NJE |
| Received date | Mar 15, 2019 |
| Decision date | Apr 12, 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: