PMA P980016S955

Device: Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DDBC3D4 Evera S VR ICD DVBC3D4 Evera XT VR ICD DVBB1D4 M
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S955
Product code: LWS
Decision date: 2026-06-25
Classification: Cardiovascular
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: a material change in the pulse generator header components of the Blackwell and Aurora device families, updates to the connector stiffness test method, and relocation of incoming inspection activities

Current openFDA PMA Record#

Device: Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DDBC3D4 Evera S VR ICD DVBC3D4 Evera XT VR ICD DVBB1D4 M
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S955
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2026-06-25
Decision code: APPR
Date received: 2026-03-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: a material change in the pulse generator header components of the Blackwell and Aurora device families, updates to the connector stiffness test method, and relocation of incoming inspection activities