PMA P980016S953

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 I CD; Ev
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S953
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: 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 I CD; Ev
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S953
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