PMA P150033S163

Device
Micra AV TPS, Micra TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S163
Product code
PNJ
Decision date
2022-11-28
Generic name
Leadless pacemaker
Approval order statement
Update the end cap welder monitoring equipment at Medtronic Swiss Operations.

Current openFDA PMA Record#

Device
Micra AV TPS, Micra TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S163
Product code
PNJ
Generic name
Leadless pacemaker
Decision date
2022-11-28
Decision code
OK30
Date received
2022-11-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update the end cap welder monitoring equipment at Medtronic Swiss Operations.