# Medtronic Cardiac Rhythm Disease Management: PMA supplement approved for Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DDBC3D4 Evera S VR ICD DVB

**Score:** 30/100

| Field | Value |
|---|---|
| Sponsor | Medtronic Cardiac Rhythm Disease Management |
| Product | Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DDBC3D4 Evera S VR ICD DVBC3D4 Evera XT VR ICD DVBB1D4 M |
| Generic / ingredient | Implantable cardioverter defibrillator (non-CRT) |
| Approval | PMA supplement (device change) |
| Application | P980016 S955 |
| Decided | 2026-06-25 |
| Panel / class | Cardiovascular |
| Sponsor location | Mounds View, MN |

## Why this score


Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980016S955). Last refreshed: 2026-11-04T06:06:18.796Z.
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.