PMA P980016S963

Device: Evera MRI DF-1 ICD (DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1); Evera MRI ICD (DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4); Evera S DR
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S963
Product code: LWS
Decision date: 2026-07-31
Classification: Cardiovascular
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: to update test methodology and parameters for screening of integrated circuits used in Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators

Current openFDA PMA Record#

Device: Evera MRI DF-1 ICD (DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1); Evera MRI ICD (DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4); Evera S DR
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S963
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2026-07-31
Decision code: OK30
Date received: 2026-07-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to update test methodology and parameters for screening of integrated circuits used in Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Defibrillators