可吸收的膠原蛋白止血劑
PMA 核准號：P170012 · 2026-09-03
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決定日期2026-09-03
PMA 編號P170012
產品代碼PMX
器械分類3 類
醫療專科G
法規編號21 CFR 8
諮詢委員會SU
請提供完整的描述文本，以便我進行翻譯。
器材摘要
Absorbable collagen hemostatic agent with thrombin is the device name listed in this FDA 510(k) record. The listed applicant is Dilon Technologies, Inc.. It received FDA 510(k) clearance on 2026-09-03. The device is classified under product code PMX. It was reviewed by the SU advisory panel.
常見問題
What is the Absorbable collagen hemostatic agent with thrombin?
Absorbable collagen hemostatic agent with thrombin is a medical device that received FDA 510(k) clearance on 2026-09-03. The listed applicant is Dilon Technologies, Inc..
When did Absorbable collagen hemostatic agent with thrombin receive FDA 510(k) clearance?
The clearance date for Absorbable collagen hemostatic agent with thrombin can be found in the official FDA records.
誰是可吸收膠原凝血劑（凝血酶）的登記申請人？
The FDA 510(k) record lists Dilon Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
FDA產品代碼是什麼？Absorbable collagen hemostatic agent with thrombin的FDA產品代碼是什麼？
FDA產品代碼為吸收性膠原凝血劑（含凝血酶）的為PMX。
相關臨床試驗
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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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