PMA P850051S084

Device: ACTIVITRAX, ACTIVITRAX II, LEGEND, LEGEND II, MICRO MINIX, MINIX, MINIX ST, PREMIER, PREVAIL,VITATRON LEGACY SR
Applicant: Medtronic, Inc.
PMA number: P850051
Supplement: S084
Product code: LWP
Decision date: 2015-08-17
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.

Current openFDA PMA Record

Device: ACTIVITRAX, ACTIVITRAX II, LEGEND, LEGEND II, MICRO MINIX, MINIX, MINIX ST, PREMIER, PREVAIL,VITATRON LEGACY SR
Applicant: Medtronic, Inc.
PMA number: P850051
Supplement: S084
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2015-08-17
Decision code: APPR
Date received: 2015-07-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.