HDE supplement
H050001 S058: GATEWAY PTA BALLOON CATHETER
FDA HDE supplement · normal 75 day track · STRYKER CORP.
Key facts
| Original HDE | H050001 |
|---|---|
| Supplement number | S058 |
| Supplement type | normal 75 day track |
| 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 | Jun 17, 2013 |
| Decision date | Oct 4, 2013 |
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: