- Device
- Cobalt MRI ICD,Cobalt XT MRI ICD,Crome MRI ICD,Evera MRI DF-1 ICD,Evera MRI ICD,Evera S DR ICD,Evera S VR ICD,Evera XT D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S741
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-06-08
- Decision code
- OK30
- Date received
- 2020-05-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify final visual inspection requirements for hybrid modules.