PMA P980016S729

Device: Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S729
Product code: LWS
Decision date: 2020-03-06
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Transfer two incoming inspection activities for device components from Medtronic Rice Creek to Medtronic Puerto Rico Operations Company Villalba/Juncos sites.

Current openFDA PMA Record#

Device: Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S729
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2020-03-06
Decision code: OK30
Date received: 2020-02-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Transfer two incoming inspection activities for device components from Medtronic Rice Creek to Medtronic Puerto Rico Operations Company Villalba/Juncos sites.