PMA P980016S965

Device: Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S965
Product code: LWS
Decision date: 2026-09-25
Classification: Cardiovascular
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: updates to visual inspection criteria for anode components at the Medtronic Energy and Component Center (MECC)

Current openFDA PMA Record#

Device: Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S965
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2026-09-25
Decision code: OK30
Date received: 2026-08-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: updates to visual inspection criteria for anode components at the Medtronic Energy and Component Center (MECC)