PMA supplement
P980016 S618: EVERA MRI XT DR SURESCAN MODELS DDMB1D4, EVERA MRI ST VR SURESCAN MODEL DVMB1D4, VISIA AF MRI VR SURESCAN DVFC3D4 IMPLAN
FDA PMA supplement · Real-Time Process · Medtronic Cardiac Rhythm Disease Management
Key facts
| Original PMA | P980016 |
|---|---|
| Supplement number | S618 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | EVERA MRI XT DR SURESCAN MODELS DDMB1D4, EVERA MRI ST VR SURESCAN MODEL DVMB1D4, VISIA AF MRI VR SURESCAN DVFC3D4 IMPLAN |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Product code | LWS |
| Received date | Jan 25, 2017 |
| 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: