PMA supplement
P950037 S296: Edora 8 DR-T 407145; Evity 8 DR-T 407146; Enitra 8 DR-T 407147; Enticos 8 DR-T 407148; Evity 6 DR-T 407149; Enitra 6 DR-
FDA PMA supplement · Real-Time Process · Biotronik, Inc.
Key facts
| Original PMA | P950037 |
|---|---|
| Supplement number | S296 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Edora 8 DR-T 407145; Evity 8 DR-T 407146; Enitra 8 DR-T 407147; Enticos 8 DR-T 407148; Evity 6 DR-T 407149; Enitra 6 DR- |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | Biotronik, Inc. |
| Product code | DXY |
| Received date | Jul 13, 2026 |
| Decision date | Oct 9, 2026 |
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: