PMA P980016S846

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, E
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S846
Product code: LWS
Decision date: 2023-01-26
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Addition of a second welder, alignment of FACTORYworks PODs, and equipment layout changes to increase manufacturing capacity of AVM capacitors at Medtronic Energy and Component Center.

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 ICD, E
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S846
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2023-01-26
Decision code: OK30
Date received: 2023-01-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a second welder, alignment of FACTORYworks PODs, and equipment layout changes to increase manufacturing capacity of AVM capacitors at Medtronic Energy and Component Center.