PMA supplement
P980016 S609: Evera MRI XT DR /VR SureScan; Evera MRI S DR/VR SureScan; Visia AF MRI XT Surescan; Visia AF MRI S VR Surescan DVFC3D4 A
FDA PMA supplement · Normal 180 Day Track · Medtronic Cardiac Rhythm Disease Management
Key facts
| Original PMA | P980016 |
|---|---|
| Supplement number | S609 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Evera MRI XT DR /VR SureScan; Evera MRI S DR/VR SureScan; Visia AF MRI XT Surescan; Visia AF MRI S VR Surescan DVFC3D4 A |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Product code | LWS |
| Received date | Nov 2, 2016 |
| Decision date | Apr 25, 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: