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FDA PMA

外科心脏消融装置,用于治疗心房颤动

PMA编号:P100046 · 2026-09-24

决定日期2026-09-24
PMA 编号P100046
产品代码OCM
设备分类第3类
医疗专科U
咨询委员会CV

器械摘要

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.

常见问题

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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