PMA P010031S500

Device: APPLICATION SOFTWARE, BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S500
Product code: KRG
Decision date: 2015-06-04
Classification: Programmer, Pacemaker
Generic name: Programmer, pacemaker
Approval order statement: APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.

Current openFDA PMA Record#

Device: APPLICATION SOFTWARE, BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S500
Product code: KRG
Generic name: Programmer, pacemaker
Decision date: 2015-06-04
Decision code: APPR
Date received: 2015-04-14
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.