HDE supplement
H060002 S008: SPIRATION VALVE SYSTEM (INCLUDING AIRWAY SIZING KIT)
FDA HDE supplement · normal 75 day track · Gyrus ACMI, Inc.
Key facts
| Original HDE | H060002 |
|---|---|
| Supplement number | S008 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | SPIRATION VALVE SYSTEM (INCLUDING AIRWAY SIZING KIT) |
| Generic name | One-way air-leak valve |
| Applicant | Gyrus ACMI, Inc. |
| Product code | OAZ |
| Received date | Nov 12, 2015 |
| Decision date | Apr 26, 2016 |
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: