HDE supplement
H100006 S009: Amyotrophic Lateral Sclerosis
FDA HDE supplement · 30-day notice · SYNAPSE BIOMEDICAL
Key facts
| Original HDE | H100006 |
|---|---|
| Supplement number | S009 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | Amyotrophic Lateral Sclerosis |
| Generic name | Diaphragmatic/phrenic nerve laparoscopically-implanted stimulator |
| Applicant | SYNAPSE BIOMEDICAL |
| Product code | OIR |
| Received date | Feb 11, 2019 |
| Decision date | Mar 13, 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: