PMA P150033S208

Device
MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S208
Product code
PNJ
Decision date
2025-08-20
Classification
Cardiovascular
Generic name
Leadless pacemaker
Approval order statement
software update to CareLink SmartSync Micra VR2 AV2 Application (D00U022)

Current openFDA PMA Record#

Device
MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S208
Product code
PNJ
Generic name
Leadless pacemaker
Decision date
2025-08-20
Decision code
APPR
Date received
2025-05-30
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
software update to CareLink SmartSync Micra VR2 AV2 Application (D00U022)