PMA P090013S301

Device: REVO MRI SURESCAN IPG AND PACING SYSTEM
Applicant: Medtronic, Inc.
Product code: LWP
Decision date: 2020-04-23
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Approval for Cobalt XT, Cobalt, and Crome MRI SureScan Implantable Cardioverter Defibrillator (ICD) and ICD with Cardiac Resynchronization Systems.

Current openFDA PMA Record#

Device: REVO MRI SURESCAN IPG AND PACING SYSTEM
Applicant: Medtronic, Inc.
PMA number: P090013
Supplement: S301
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2020-04-23
Decision code: APPR
Date received: 2019-07-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for Cobalt XT, Cobalt, and Crome MRI SureScan Implantable Cardioverter Defibrillator (ICD) and ICD with Cardiac Resynchronization Systems.