PMA supplement
P160039 S004: remede® System
FDA PMA supplement · Normal 180 Day Track · Respicardia
Key facts
| Original PMA | P160039 |
|---|---|
| Supplement number | S004 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | remede® System |
| Generic name | Implanted phrenic nerve stimulator for central sleep apnea |
| Applicant | Respicardia |
| Product code | PSR |
| Received date | Oct 16, 2018 |
| Decision date | Jan 30, 2019 |
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: