HDE supplement
H060002 S014: Spiration Valve System (SVS), Spiration Valve System Deployment Catheter and Loader
FDA HDE supplement · 30-day notice · Gyrus ACMI, Inc.
Key facts
| Original HDE | H060002 |
|---|---|
| Supplement number | S014 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | Spiration Valve System (SVS), Spiration Valve System Deployment Catheter and Loader |
| Generic name | One-way air-leak valve |
| Applicant | Gyrus ACMI, Inc. |
| Product code | OAZ |
| Received date | May 2, 2024 |
| Decision date | May 30, 2024 |
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: