PMA P150033S152

Device
Micra AV TPS, Micra TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S152
Product code
PNJ
Decision date
2022-09-16
Generic name
Leadless pacemaker
Approval order statement
Implement modifications to the battery manufacturing process at MECC.

Current openFDA PMA Record#

Device
Micra AV TPS, Micra TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S152
Product code
PNJ
Generic name
Leadless pacemaker
Decision date
2022-09-16
Decision code
OK30
Date received
2022-09-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implement modifications to the battery manufacturing process at MECC.