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FDA PMA

Leadless Cardiac Resynchronization Therapy (CRT)

PMA Number: P240028 · 2026-03-27

ApplicantEBR Systems, Inc.
Decision Date2026-03-27
PMA NumberP240028
Product CodeSEG
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Leadless Cardiac Resynchronization Therapy (CRT) is the device name listed in this FDA 510(k) record. The listed applicant is EBR Systems, Inc.. It received FDA 510(k) clearance on 2026-03-27. The device is classified under product code SEG. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Leadless Cardiac Resynchronization Therapy (CRT)?

Leadless Cardiac Resynchronization Therapy (CRT) is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is EBR Systems, Inc..

When did Leadless Cardiac Resynchronization Therapy (CRT) receive FDA 510(k) clearance?

The clearance date for Leadless Cardiac Resynchronization Therapy (CRT) can be found in the official FDA records.

Who is the listed applicant for Leadless Cardiac Resynchronization Therapy (CRT)?

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

What is the FDA product code for Leadless Cardiac Resynchronization Therapy (CRT)?

The FDA product code for Leadless Cardiac Resynchronization Therapy (CRT) is SEG.

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.

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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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