FDA PMA

Leadless Cardiac Resynchronization Therapy (CRT)

Número do PMA: P240028 · 2026-03-27

RequerenteEBR Systems, Inc.

Data da decisão2026-03-27

Número PMAP240028

Código do produtoSEG

Classe do DispositivoClasse 3

Especialidade MédicaU

Comité consultivoCV

Resumo do dispositivo

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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.