PMA P220012S071
- Device
- Aurora EV ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD
- Applicant
- Medtronic, Inc.
- PMA number
- P220012
- Supplement
- S071
- Product code
- LWS
- Decision date
- 2026-04-28
- Classification
- Cardiovascular
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- an alternate supplier for printed wiring board of the transformer component
Current openFDA PMA Record#
- Device
- Aurora EV ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD
- Applicant
- Medtronic, Inc.
- PMA number
- P220012
- Supplement
- S071
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-04-28
- Decision code
- OK30
- Date received
- 2026-04-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate supplier for printed wiring board of the transformer component