PMA P990001S096

Device: DIVA IPG FAMILY, DEMA IPG FAMILY, & VARIOUS C-SERIES & T-SERIES DEVICES
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S096
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: DIVA IPG FAMILY, DEMA IPG FAMILY, & VARIOUS C-SERIES & T-SERIES DEVICES
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S096
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.