PMA P850051S072

Device
Model 2090 Medtronic Carelink Programmer
Applicant
MEDTRONIC Inc.
PMA number
P850051
Supplement
S072
Decision date
2010-05-11

Current openFDA PMA Record

Device
MODEL 2090 MEDTRONIC CARELINK PROGRAMMER
Applicant
Medtronic, Inc.
PMA number
P850051
Supplement
S072
Product code
LWO
Generic name
Pulse-generator, single chamber, sensor driven, implantable
Decision date
2010-05-11
Decision code
APPR
Date received
2010-03-01
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR ENHANCEMENTS TO THE MODEL 9986 SOFTWARE. THE MODEL 9986 SOFTWARE IS THE DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.

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