PMA P150033S226

Device
Micra AV TPS; Micra AV2 TPS; Micra TPS; Micra VR2 TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S226
Product code
PNJ
Decision date
2026-04-30
Classification
Cardiovascular
Generic name
Leadless pacemaker
Approval order statement
to expand the electrolyte salt acceptance limits

Current openFDA PMA Record#

Device
Micra AV TPS; Micra AV2 TPS; Micra TPS; Micra VR2 TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S226
Product code
PNJ
Generic name
Leadless pacemaker
Decision date
2026-04-30
Decision code
OK30
Date received
2026-04-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to expand the electrolyte salt acceptance limits