PMA P150033S130

Device
Micra AV TPS, Micra TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S130
Product code
PNJ
Decision date
2022-01-18
Generic name
Leadless pacemaker
Approval order statement
New cleaning basket and transport bin used in manufacturing at Medtronic Tempe Campus.

Current openFDA PMA Record#

Device
Micra AV TPS, Micra TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S130
Product code
PNJ
Generic name
Leadless pacemaker
Decision date
2022-01-18
Decision code
OK30
Date received
2022-01-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New cleaning basket and transport bin used in manufacturing at Medtronic Tempe Campus.