HDE
H100006: NEURX DIAPHRAGM PACING SYSTEM (DPS)
FDA Humanitarian Device Exemption · SYNAPSE BIOMEDICAL
Key facts
| HDE number | H100006 |
|---|---|
| Trade name | NEURX DIAPHRAGM PACING SYSTEM (DPS) |
| Generic name | Diaphragmatic/phrenic nerve laparoscopically-implanted stimulator |
| Applicant | SYNAPSE BIOMEDICAL |
| Owner/operator | Synapse Biomedical Inc. |
| Product code | OIR |
| Approval date | Sep 28, 2011 |
| Docket number | 11-M0707 |
| Establishment registration | 3005868392 |
| FEI number | 3005868392 |
At a glance
- 10–99 Supplements
- Nov 7, 2020 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 1–9 MAUDE adverse event reports
- 1–9 Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: