PMA P980016S959

Device: Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICD, Primo MRI VR ICD,
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S959
Product code: LWS
Decision date: 2026-07-16
Classification: Cardiovascular
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: approval of new burn-in equipment and process for electrical testing of capacitors

Current openFDA PMA Record#

Device: Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICD, Primo MRI VR ICD,
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S959
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2026-07-16
Decision code: OK30
Date received: 2026-06-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval of new burn-in equipment and process for electrical testing of capacitors