PMA supplement
P160039 S011: remede System
FDA PMA supplement · Normal 180 Day Track · Respicardia
Key facts
| Original PMA | P160039 |
|---|---|
| Supplement number | S011 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | remede System |
| Generic name | Implanted phrenic nerve stimulator for central sleep apnea |
| Applicant | Respicardia |
| Product code | PSR |
| Received date | Feb 6, 2025 |
| Decision date | May 7, 2025 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: