PMA supplement
P070008 S123: Evia HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Eni
FDA PMA supplement · 30-Day Notice · Biotronik, Inc.
Key facts
| Original PMA | P070008 |
|---|---|
| Supplement number | S123 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Evia HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Eni |
| Generic name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
| Applicant | Biotronik, Inc. |
| Product code | NKE |
| Received date | Mar 18, 2021 |
| Decision date | Apr 14, 2021 |
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: