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FDA PMA

Leadless pacemaker

PMA Number: P150035 · 2026-08-27

ApplicantABBOTT MEDICAL
Decision Date2026-08-27
PMA NumberP150035
Product CodePNJ
Device ClassClass 3
Medical SpecialtyC
Regulation Number21 CFR 8
Advisory CommitteeCV

Device Summary

Leadless pacemaker is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-08-27. The device is classified under product code PNJ. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Leadless pacemaker?

Leadless pacemaker is a medical device that received FDA 510(k) clearance on 2026-08-27. The listed applicant is ABBOTT MEDICAL.

When did Leadless pacemaker receive FDA 510(k) clearance?

The clearance date for Leadless pacemaker can be found in the official FDA records.

Who is the listed applicant for Leadless pacemaker?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Leadless pacemaker?

The FDA product code for Leadless pacemaker is PNJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Related PubMed Literature

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMID: 37209414Adverse events associated with AveirTM VR leadless pacemaker: A Food and Drug Administration MAUDE database study.Journal of cardiovascular electrophysiology ()

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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