PMA P980016S755

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, Eve
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S755
Product code: LWS
Decision date: 2020-09-30
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Implementation of modifications of selected manufacturing processes related to the packaging processes associated with the Backfill Hole Weld 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 ICD, Eve
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S755
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2020-09-30
Decision code: OK30
Date received: 2020-09-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of modifications of selected manufacturing processes related to the packaging processes associated with the Backfill Hole Weld Process.