PMA P920015S270

Device: Sprint Quattro Secure MRI SureScan Model 6947M lead, Sprint Quattro Secure S MRI SureScan Model 6935M lead
Applicant: Medtronic, Inc.
PMA number: P920015
Supplement: S270
Product code: NVY
Decision date: 2022-08-26
Generic name: Permanent defibrillator electrodes
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: Sprint Quattro Secure MRI SureScan Model 6947M lead, Sprint Quattro Secure S MRI SureScan Model 6935M lead
Applicant: Medtronic, Inc.
PMA number: P920015
Supplement: S270
Product code: NVY
Generic name: Permanent defibrillator electrodes
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.