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FDA PMA

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Número do PMA: P220013 · 2026-09-22

RequerenteABBOTT MEDICAL
Data da decisão2026-09-22
Número PMAP220013
Código do produtoOAE
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoCV

Resumo do dispositivo

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-09-22. The device is classified under product code OAE. It was reviewed by the CV advisory panel.

Perguntas frequentes

What is the Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation?

Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation is a medical device that received FDA 510(k) clearance on 2026-09-22. The listed applicant is ABBOTT MEDICAL.

When did Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation receive FDA 510(k) clearance?

The clearance date for Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation can be found in the official FDA records.

Who is the listed applicant for Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation?

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 Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation?

The FDA product code for Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation is OAE.

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