PMA supplement
P050023 S128: Ilesto 7 VR-T, Iforia 7 VR-T, Ilesto 5 VR-T, Iforia 5 VR-T, Inventra 7 VR-T, Iperia 7 VR-T, Itrevia 7 VR-T, Iperia 5 VR-
FDA PMA supplement · Normal 180 Day Track No User Fee · Biotronik, Inc.
Key facts
| Original PMA | P050023 |
|---|---|
| Supplement number | S128 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | Ilesto 7 VR-T, Iforia 7 VR-T, Ilesto 5 VR-T, Iforia 5 VR-T, Inventra 7 VR-T, Iperia 7 VR-T, Itrevia 7 VR-T, Iperia 5 VR- |
| Generic name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
| Applicant | Biotronik, Inc. |
| Product code | MRM |
| Received date | Dec 11, 2018 |
| Decision date | Apr 15, 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: