PMA P090013S281

Device: Revo MRI SureScan and CapSureFix MRI SureScan Lead
Applicant: Medtronic, Inc.
PMA number: P090013
Supplement: S281
Product code: LWP
Decision date: 2018-06-28
Classification: Implantable Pulse Generator, Pacemaker (non-crt)
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Approval for an update to the indications for use to include pacing at the bundle of His. The device, as modified, will be marketed under the trade name SelectSecure MRI SureScan Lead Model 3830 and is indicated for: The Model 3830 lead is intended for pacing and sensing in the atrium or right ventricle. It is also intended for pacing and sensing at the bundle of His as an alternative to right ventricular pacing in a single or dual chamber pacing system.

Current openFDA PMA Record#

Device: Revo MRI SureScan and CapSureFix MRI SureScan Lead
Applicant: Medtronic, Inc.
PMA number: P090013
Supplement: S281
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2018-06-28
Decision code: APPR
Date received: 2018-04-13
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for an update to the indications for use to include pacing at the bundle of His. The device, as modified, will be marketed under the trade name SelectSecure MRI SureScan Lead Model 3830 and is indicated for: The Model 3830 lead is intended for pacing and sensing in the atrium or right ventricle. It is also intended for pacing and sensing at the bundle of His as an alternative to right ventricular pacing in a single or dual chamber pacing system.