PMA supplement
P950037 S176: Edora, Evity, Enitra, Enticos 8SR/ SR-T/ DR/ DR-T
FDA PMA supplement · Real-Time Process · BIOTRONIK, INC.
Key facts
| Original PMA | P950037 |
|---|---|
| Supplement number | S176 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Edora, Evity, Enitra, Enticos 8SR/ SR-T/ DR/ DR-T |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | BIOTRONIK, INC. |
| Product code | DXY |
| Received date | May 5, 2017 |
| Decision date | Aug 2, 2017 |
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: