- Device
- Aurora EV ICD DVEA3E4
- Applicant
- Medtronic, Inc.
- PMA number
- P220012
- Supplement
- S069
- 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