PMA P150033S129

Device
Micra AV TPS, Micra TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S129
Product code
PNJ
Decision date
2021-12-09
Generic name
Leadless pacemaker
Approval order statement
Implement a new electrostatic discharge handling tray used in manufacturing at Medtronic's internal supplier - Medtronic Tempe Campus.

Current openFDA PMA Record#

Device
Micra AV TPS, Micra TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S129
Product code
PNJ
Generic name
Leadless pacemaker
Decision date
2021-12-09
Decision code
OK30
Date received
2021-11-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implement a new electrostatic discharge handling tray used in manufacturing at Medtronic's internal supplier - Medtronic Tempe Campus.