PMA P980016S825

Device: Evera MRI XT DR SureScan Model DDMB1D4, Evera MRI XT VR SureScan Model DVMB1DA, Evera MRI S DR SureScan Model DDMC3D4, E
Applicant: Medtronic Cardiac Rhythm Disease Management
Product code: LWS
Decision date: 2022-08-26
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Approval for addition of the summary for your Post Approval Study, Pacing Capture Threshold (PCT) Change Following 3T MRI Scan of MR Conditional CIEDs, to the labeling.

Current openFDA PMA Record#

Device: Evera MRI XT DR SureScan Model DDMB1D4, Evera MRI XT VR SureScan Model DVMB1DA, Evera MRI S DR SureScan Model DDMC3D4, E
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S825
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2022-08-26
Decision code: APPR
Date received: 2022-06-17
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for addition of the summary for your Post Approval Study, Pacing Capture Threshold (PCT) Change Following 3T MRI Scan of MR Conditional CIEDs, to the labeling.