Premarket Approval (PMA) | 合法醫療器材資訊網
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.
Learn more...[1]
References Learn more... (www.fda.gov)
"ACS" STACK PERFUSION DILATION CATHETER "ACS" STACK PERFUSION DILATION CATHETER 伊藤 電位治療器 GORE-TEX PERIODONTAL MATERIAL “歐居”電刺激器 醫兆股份有限公司高雄 arkray台灣 醫兆股份有限公司林口 羅氏可霸斯血漿銅藍蛋白檢驗試劑 Propaten graft
血管擴張導管"ACS" STACK PERFUSION DILATION CATHETER ... | 合法醫療器材資訊網
Premarket Approval (PMA) | 合法醫療器材資訊網
Prolonged dilation with an autoperfusion balloon catheter for ... | 合法醫療器材資訊網
Therapy for acute vascular complications in percutaneous ... | 合法醫療器材資訊網
ACS R STACK PERFUSION DILATATION CATHETER 510(k) FDA ... | 合法醫療器材資訊網
PTCA | 合法醫療器材資訊網
相關資訊整理
【血管擴張導管】許可證字號:衛署醫器輸字第005975號
器材品名:血管擴張導管許可證字號:衛署醫器輸字第005975號註銷狀態:已註銷註銷日期:2004/11/17註銷理由:未展延而逾期者有效...