PMA P220012S074
- Device
- Aurora EV ICD (DVEA3E4)
- Applicant
- Medtronic, Inc.
- PMA number
- P220012
- Supplement
- S074
- Product code
- LWS
- Decision date
- 2026-07-31
- Classification
- Cardiovascular
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- changes to cleaning process and revising acceptance criteria for final visual inspection of hybrid subassembly
Current openFDA PMA Record#
- Device
- Aurora EV ICD (DVEA3E4)
- Applicant
- Medtronic, Inc.
- PMA number
- P220012
- Supplement
- S074
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-07-31
- Decision code
- OK30
- Date received
- 2026-07-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to cleaning process and revising acceptance criteria for final visual inspection of hybrid subassembly