PMA P150033S133

Device
Micra AV TPS, Micra TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S133
Product code
PNJ
Decision date
2022-02-01
Generic name
Leadless pacemaker
Approval order statement
Modify the final function test at Medtronic Swiss Manufacturing Operations.

Current openFDA PMA Record#

Device
Micra AV TPS, Micra TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S133
Product code
PNJ
Generic name
Leadless pacemaker
Decision date
2022-02-01
Decision code
OK30
Date received
2022-01-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modify the final function test at Medtronic Swiss Manufacturing Operations.