HDE supplement
H070003 S001: NEURX RA/4 DEVICE
FDA HDE supplement · normal 75 day track · SYNAPSE BIOMEDICAL
Key facts
| Original HDE | H070003 |
|---|---|
| Supplement number | S001 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | NEURX RA/4 DEVICE |
| Generic name | Diaphragmatic/phrenic nerve laparoscopically-implanted stimulator |
| Applicant | SYNAPSE BIOMEDICAL |
| Product code | OIR |
| Received date | Oct 20, 2008 |
| Decision date | Feb 3, 2009 |
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: