PMA P090013S063

Device: REVO MRI IPG, ENRHYTHM MRI IPG
Applicant: Medtronic, Inc.
PMA number: P090013
Supplement: S063
Product code: LWP
Decision date: 2013-02-19
Classification: Implantable Pulse Generator, Pacemaker (non-crt)
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: APPROVAL FOR LABELING UPDATES TO INCORPORATE THE RESULTS OF THE RESPECT POST APPROVAL STUDY FINAL REPORT, AND ADDITIONAL LABELING UPDATES.

Current openFDA PMA Record#

Device: REVO MRI IPG, ENRHYTHM MRI IPG
Applicant: Medtronic, Inc.
PMA number: P090013
Supplement: S063
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2013-02-19
Decision code: APPR
Date received: 2012-08-21
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING UPDATES TO INCORPORATE THE RESULTS OF THE RESPECT POST APPROVAL STUDY FINAL REPORT, AND ADDITIONAL LABELING UPDATES.