Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA PMA

Percutaneously Delivered Prostheses and Tricuspid Valves

Número do PMA: P230013 · 2026-09-16

RequerenteEdwards Lifesciences, LLC
Data da decisão2026-09-16
Número PMAP230013
Código do produtoNPW
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoCV

Resumo do dispositivo

Percutaneously Delivered Prostheses and Tricuspid Valves is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2026-09-16. The device is classified under product code NPW. It was reviewed by the CV advisory panel.

Perguntas frequentes

What is the Percutaneously Delivered Prostheses and Tricuspid Valves?

Percutaneously Delivered Prostheses and Tricuspid Valves is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Edwards Lifesciences, LLC.

When did Percutaneously Delivered Prostheses and Tricuspid Valves receive FDA 510(k) clearance?

The clearance date for Percutaneously Delivered Prostheses and Tricuspid Valves can be found in the official FDA records.

Who is the listed applicant for Percutaneously Delivered Prostheses and Tricuspid Valves?

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

What is the FDA product code for Percutaneously Delivered Prostheses and Tricuspid Valves?

The FDA product code for Percutaneously Delivered Prostheses and Tricuspid Valves is NPW.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial 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.

↑