PMA
P160039: remede® System
FDA PMA · Implanted phrenic nerve stimulator for central sleep apnea · Respicardia
Key facts
| PMA number | P160039 |
|---|---|
| Trade name | remede® System |
| Generic name | Implanted phrenic nerve stimulator for central sleep apnea |
| Applicant | Respicardia |
| Owner/operator | Respicardia, Inc. |
| Product code | PSR |
| Approval date | Oct 6, 2017 |
| Docket number | 17M-6223 |
| Notice date | Oct 23, 2017 |
| Establishment registration | 3009144177 |
| FEI number | 3009144177 |
At a glance
- 10–99 Supplements
- May 7, 2025 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- No Withdrawn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: