PMA P850051S080

Device: ACTIVITRAX,ACTIVITRAX II,ACTIVITRAX E,LEGEND,LEGEND II,MICRO MINIX,MINIX ST,PREMIER,PREVAIL,VITATRON LEGACY
Applicant: Medtronic, Inc.
PMA number: P850051
Supplement: S080
Product code: LWP
Decision date: 2013-06-11
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.

Current openFDA PMA Record

Device: ACTIVITRAX,ACTIVITRAX II,ACTIVITRAX E,LEGEND,LEGEND II,MICRO MINIX,MINIX ST,PREMIER,PREVAIL,VITATRON LEGACY
Applicant: Medtronic, Inc.
PMA number: P850051
Supplement: S080
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2013-06-11
Decision code: APPR
Date received: 2013-04-18
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR ENHANCEMENTS TO MODEL 9986 DESKTOP/BOSS FOR USE ON THE MODEL 2090 MEDTRONIC CARELINK PROGRAMMER FOR THE DEVICES.