PMA P150033S077

Device
Micra TPS
Applicant
Medtronic, Inc.
Product code
PNJ
Decision date
2020-09-29
Generic name
Leadless pacemaker
Approval order statement
Approval for updates to the Model SW016, Model SW033, and Model SW022 programmer applications to update the H3 Battery Longevity Estimator functionality.

Current openFDA PMA Record#

Device
Micra TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S077
Product code
PNJ
Generic name
Leadless pacemaker
Decision date
2020-09-29
Decision code
APPR
Date received
2020-07-02
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for updates to the Model SW016, Model SW033, and Model SW022 programmer applications to update the H3 Battery Longevity Estimator functionality.