PMA supplement
P950037 S191: Evia DR /DR-T /SR/SR-T;/Entovis DR /DR-T /SR /SR-T; Estella DR / DR-T/ SR /SR-T; Effecta D /S;/ Endora 8 DR/ 8 SR; /
FDA PMA supplement · 30-Day Notice · Biotronik, Inc.
Key facts
| Original PMA | P950037 |
|---|---|
| Supplement number | S191 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Evia DR /DR-T /SR/SR-T ;/Entovis DR /DR-T /SR /SR-T; Estella DR / DR-T/ SR /SR-T; Effecta D /S ;/ Endora 8 DR/ 8 SR; / |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | Biotronik, Inc. |
| Product code | DXY |
| Received date | May 18, 2018 |
| Decision date | Jun 13, 2018 |
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: