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FDA PMA

Surgical cardiac ablation device, for treatment of atrial fibrillation

PMA 核准號:P100046 · 2026-09-24

決定日期2026-09-24
PMA 編號P100046
產品代碼OCM
器械分類3 類
醫療專科U
諮詢委員會CV

器材摘要

Surgical cardiac ablation device, for treatment of atrial fibrillation is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2026-09-24. The device is classified under product code OCM. It was reviewed by the CV advisory panel.

常見問題

What is the Surgical cardiac ablation device, for treatment of atrial fibrillation?

Surgical cardiac ablation device, for treatment of atrial fibrillation is a medical device that received FDA 510(k) clearance on 2026-09-24. The listed applicant is AtriCure, Inc..

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

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

Who is the listed applicant for Surgical cardiac ablation device, for treatment of atrial fibrillation?

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

What is the FDA product code for Surgical cardiac ablation device, for treatment of atrial fibrillation?

The FDA product code for Surgical cardiac ablation device, for treatment of atrial fibrillation is OCM.

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