PMA P930022S013

Device: LEGEND PLUS
Applicant: Medtronic, Inc.
PMA number: P930022
Supplement: S013
Product code: NVZ
Decision date: 2011-11-17
Generic name: Pulse generator, permanent, 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: LEGEND PLUS
Applicant: Medtronic, Inc.
PMA number: P930022
Supplement: S013
Product code: NVZ
Generic name: Pulse generator, permanent, 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.