PMA P850051S078

Device: VITATRON LEGACY, PREVAIL, PREMIER, & VARIOUS FAMILIES/MODELS OF ACTIVITRAX, LEGEND, MINIX
Applicant: Medtronic, Inc.
PMA number: P850051
Supplement: S078
Product code: LWO
Decision date: 2011-11-17
Generic name: Pulse-generator, single chamber, sensor driven, implantable
Approval order statement: APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.

Current openFDA PMA Record

Device: VITATRON LEGACY, PREVAIL, PREMIER, & VARIOUS FAMILIES/MODELS OF ACTIVITRAX, LEGEND, MINIX
Applicant: Medtronic, Inc.
PMA number: P850051
Supplement: S078
Product code: LWO
Generic name: Pulse-generator, single chamber, sensor driven, implantable
Decision date: 2011-11-17
Decision code: APPR
Date received: 2011-09-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.