FDA PMA

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

PMA番号：P030031 · 2026-09-15

決定日2026-09-15

PMA番号P030031

製品コードOAD

デバイスクラスクラス3

診療科U

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- **政策：medical-regulatory-v1** --- [ここに原文が記載されています] --- **会社名/製品名**：[ここに会社名または製品名が記載されています] **FDA**：食品医薬品局 **510(k)**：510(k)届出 **PMA**：プレマーケティング評価届出 **NCT**：臨床試験登録番号 **PMID**：PubMed ID **識別子**：[ここに識別子が記載されています] **URL**：[ここにURLが記載されています]

医療機器の概要

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster, Inc.. It received FDA 510(k) clearance on 2026-09-15. The device is classified under product code OAD. It was reviewed by the CV advisory panel.

よくある質問

What is the catheter, percutaneous, cardiac ablation, for treatment of atrial flutter?

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter is a medical device that received FDA 510(k) clearance on 2026-09-15. The listed applicant is Biosense Webster, Inc..

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

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

Who is the listed applicant for catheter, percutaneous, cardiac ablation, for treatment of atrial flutter?

The FDA 510(k) record lists Biosense Webster, Inc. 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 flutter?

The FDA product code for catheter, percutaneous, cardiac ablation, for treatment of atrial flutter is OAD.

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医療機器の概要

よくある質問

関連する臨床試験

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