PMA P220012S075

Device: Aurora EV-ICD (DVEA3E4)
Applicant: Medtronic, Inc.
PMA number: P220012
Supplement: S075
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: Aurora EV-ICD (DVEA3E4)
Applicant: Medtronic, Inc.
PMA number: P220012
Supplement: S075
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