PMA
P200018: NeuRX Diaphragm Pacing System (DPS)
FDA PMA · Diaphragmatic/phrenic nerve laparoscopically-implanted stimulator · Synapse Biomedical, Inc.
Key facts
| PMA number | P200018 |
|---|---|
| Trade name | NeuRX Diaphragm Pacing System (DPS) |
| Generic name | Diaphragmatic/phrenic nerve laparoscopically-implanted stimulator |
| Applicant | Synapse Biomedical, Inc. |
| Owner/operator | Synapse Biomedical Inc. |
| Product code | OIR |
| Approval date | Mar 31, 2023 |
| Docket number | 23M-1306 |
| Notice date | Apr 6, 2023 |
| Establishment registration | 3005868392 |
| FEI number | 3005868392 |
At a glance
- None Supplements
- Mar 31, 2023 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: