PMA P010031S413

Device: BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,VIVA/BRAVA/EVERA PROGRAMMER APPLICATION SOFTWARE
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S413
Product code: KRG
Decision date: 2014-02-27
Classification: Programmer, Pacemaker
Generic name: Programmer, pacemaker
Approval order statement: APPROVAL FOR POST STERILIZATION TEST FIRMWARE, PROGRAMMER APPLICATION SOFTWARE AND LABELING FOR THE DEVICES.

Current openFDA PMA Record#

Device: BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,VIVA/BRAVA/EVERA PROGRAMMER APPLICATION SOFTWARE
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S413
Product code: KRG
Generic name: Programmer, pacemaker
Decision date: 2014-02-27
Decision code: APPR
Date received: 2013-12-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR POST STERILIZATION TEST FIRMWARE, PROGRAMMER APPLICATION SOFTWARE AND LABELING FOR THE DEVICES.