PMA P980016S841

Device: Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT VR ICD,
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S841
Product code: LWS
Decision date: 2022-11-22
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Relocation of the Chemical Operations area within the same manufacturing facility (Medtronic Energy and Component Center) for selected components.

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/VR ICD, Evera XT VR ICD,
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S841
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2022-11-22
Decision code: OK30
Date received: 2022-11-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Relocation of the Chemical Operations area within the same manufacturing facility (Medtronic Energy and Component Center) for selected components.