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FDA PMA

药物洗脱鼻窦支架

PMA编号:P100044 · 2026-09-23

决定日期2026-09-23
PMA 编号P100044
产品代码OWO
设备分类第3类
医疗专科U
咨询委员会EN

器械摘要

Drug-eluting sinus stent is the device name listed in this FDA 510(k) record. The listed applicant is Intersect Ent.. It received FDA 510(k) clearance on 2026-09-23. The device is classified under product code OWO. It was reviewed by the EN advisory panel.

常见问题

What is the Drug-eluting sinus stent?

Drug-eluting sinus stent is a medical device that received FDA 510(k) clearance on 2026-09-23. The listed applicant is Intersect Ent..

When did Drug-eluting sinus stent receive FDA 510(k) clearance?

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

Who is the listed applicant for Drug-eluting sinus stent?

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

What is the FDA product code for Drug-eluting sinus stent?

The FDA product code for Drug-eluting sinus stent is OWO.

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