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FDA PMA

冠状动脉药物洗脱支架

PMA编号:P170030 · 2026-09-24

申请人Biotronik AG
决定日期2026-09-24
PMA 编号P170030
产品代码NIQ
设备分类第3类
医疗专科U
咨询委员会CV

器械摘要

Coronary drug-eluting stent is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik AG. It received FDA 510(k) clearance on 2026-09-24. The device is classified under product code NIQ. It was reviewed by the CV advisory panel.

常见问题

What is the Coronary drug-eluting stent?

Coronary drug-eluting stent is a medical device that received FDA 510(k) clearance on 2026-09-24. The listed applicant is Biotronik AG.

When did Coronary drug-eluting stent receive FDA 510(k) clearance?

The clearance date for Coronary drug-eluting stent can be found in the official FDA records.

Who is the listed applicant for Coronary drug-eluting stent?

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

What is the FDA product code for Coronary drug-eluting stent?

The FDA product code for Coronary drug-eluting stent is NIQ.

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