PMA P150033S109

Device
Micra AV TPS, Micra TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S109
Product code
PNJ
Decision date
2021-06-04
Generic name
Leadless pacemaker
Approval order statement
Changes to the Solder Paste Inspection at Medtronic Tempe Campus (MTC).

Current openFDA PMA Record#

Device
Micra AV TPS, Micra TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S109
Product code
PNJ
Generic name
Leadless pacemaker
Decision date
2021-06-04
Decision code
OK30
Date received
2021-05-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to the Solder Paste Inspection at Medtronic Tempe Campus (MTC).