PMA P150033S212

Device: Micra Transcatheter Pacing System (Micra AV/VR and Micra AV2/VR2)
Applicant: Medtronic, Inc.
PMA number: P150033
Supplement: S212
Product code: PNJ
Decision date: 2025-08-15
Classification: Cardiovascular
Generic name: Leadless pacemaker
Approval order statement: approval for changes to the cybersecurity and adverse event information in the instructions for use for the Micra Transcatheter Pacing System.

Current openFDA PMA Record#

Device: Micra Transcatheter Pacing System (Micra AV/VR and Micra AV2/VR2)
Applicant: Medtronic, Inc.
PMA number: P150033
Supplement: S212
Product code: PNJ
Generic name: Leadless pacemaker
Decision date: 2025-08-15
Decision code: APPR
Date received: 2025-06-17
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for changes to the cybersecurity and adverse event information in the instructions for use for the Micra Transcatheter Pacing System.