PMA supplement
P980016 S645: Evera MRI DF ICD /MRI ICD / S DR / S VR / XT DR /XT VR ICD's; Visia AF MRI DFI ICD / AF MRI VR ICD / AF VR ICD.
FDA PMA supplement · 30-Day Notice · Medtronic Cardiac Rhythm Disease Management
Key facts
| Original PMA | P980016 |
|---|---|
| Supplement number | S645 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Evera MRI DF ICD /MRI ICD / S DR / S VR / XT DR /XT VR ICD's; Visia AF MRI DFI ICD / AF MRI VR ICD / AF VR ICD. |
| Generic name | Implantable cardioverter defibrillator (non-CRT) |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Product code | LWS |
| Received date | Oct 2, 2017 |
| Decision date | Oct 26, 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: