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FDA PMA

Artificial heart

PMA Number: P030011 · 2026-07-09

ApplicantSyncardia Systems, LLC
Decision Date2026-07-09
PMA NumberP030011
Product CodeLOZ
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Artificial heart is the device name listed in this FDA 510(k) record. The listed applicant is Syncardia Systems, LLC. It received FDA 510(k) clearance on 2026-07-09. The device is classified under product code LOZ. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Artificial heart?

Artificial heart is a medical device that received FDA 510(k) clearance on 2026-07-09. The listed applicant is Syncardia Systems, LLC.

When did Artificial heart receive FDA 510(k) clearance?

The clearance date for Artificial heart can be found in the official FDA records.

Who is the listed applicant for Artificial heart?

The FDA 510(k) record lists Syncardia Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Artificial heart?

The FDA product code for Artificial heart is LOZ.

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

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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