PMA P150033S088

Device
Micra AV TPS, Micra TPS
Applicant
Medtronic, Inc.
Product code
PNJ
Decision date
2021-02-09
Generic name
Leadless pacemaker
Approval order statement
Approval for updates to the MyCareLink Patient Monitor firmware.

Current openFDA PMA Record#

Device
Micra AV TPS, Micra TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S088
Product code
PNJ
Generic name
Leadless pacemaker
Decision date
2021-02-09
Decision code
APPR
Date received
2020-11-19
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for updates to the MyCareLink Patient Monitor firmware.