PMA P090013S323

Device: CapSureFix MRI SureScan Lead Model 5086MRI
Applicant: Medtronic, Inc.
PMA number: P090013
Supplement: S323
Product code: LWP
Decision date: 2022-08-26
Generic name: Implantable pulse generator, pacemaker (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: CapSureFix MRI SureScan Lead Model 5086MRI
Applicant: Medtronic, Inc.
PMA number: P090013
Supplement: S323
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (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.