PMA P850051S081

Device: ACTIVITRAX, ACTIVITRAX II, LEGEND, LEGEND II, MICRO MINIX, MINIX, MINIX ST,PREMIER, PREVAIL, VITATRON LEGACY SR
Applicant: Medtronic, Inc.
PMA number: P850051
Supplement: S081
Product code: LWP
Decision date: 2014-09-05
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, LEGEND, LEGEND II, MICRO MINIX, MINIX, MINIX ST,PREMIER, PREVAIL, VITATRON LEGACY SR
Applicant: Medtronic, Inc.
PMA number: P850051
Supplement: S081
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2014-09-05
Decision code: APPR
Date received: 2014-07-02
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.