PMA P220012S068
- Device
- Aurora EV ICD; Epsila EV Extravascular Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P220012
- Supplement
- S068
- Product code
- LWS
- Decision date
- 2026-03-06
- Classification
- Cardiovascular
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- to replace the Novec 72DA solvent with the PWR-4 3910 solvent during the component cleaning process
Current openFDA PMA Record#
- Device
- Aurora EV ICD; Epsila EV Extravascular Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P220012
- Supplement
- S068
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-03-06
- Decision code
- OK30
- Date received
- 2026-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to replace the Novec 72DA solvent with the PWR-4 3910 solvent during the component cleaning process