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Sequana Medical announces FDA acceptance for substantive

PRESS RELEASE Acceptance and filing review is a first step in the PMA review process Indicates PMA application is sufficiently complete for in-depth.

United statesTimur reschCompany premarket approvalCompany or sequanamedicalDrug administrationSequana medicalEuronext brusselsPremarket approvalGlobal vice presidentNorth americanPivotal cohortNorth american consortiumEnd stage liverNorth americaSequana medical nv

Sequana Medical NV: Sequana Medical submits Premarket Approval application to US FDA for alfapump® in recurrent or refractory ascites due to liver cirrhosis

Sequana Medical NV: Sequana Medical submits Premarket Approval application to US FDA for alfapump® in recurrent or refractory ascites due to liver cirrhosis
finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.

United statesTimur reschCian crosbieStefan klotterCompany or sequanamedicalHealth solutionsDrug administrationEuronext brusselsPremarket approvalGlobal vice presidentSequana medicalChief executive officerNorth americanPivotal cohortMajor adverse eventsNorth american consortium

Sequana Medical submits Premarket Approval application to US FDA for alfapump® in recurrent or refractory ascites due to liver cirrhosis

Sequana Medical submits Premarket Approval application to US FDA for alfapump® in recurrent or refractory ascites due to liver cirrhosis
streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.

United statesTimur reschCian crosbieHealth solutionsDrug administrationCompany or sequanamedicalSequana medicalEuronext brusselsPremarket approvalGlobal vice presidentChief executive officerNorth americanPivotal cohortMajor adverse eventsNorth american consortiumEnd stage liver

Investegate |Sequana Medical NV Announcements | Sequana Medical NV: Sequana Medical receives certification under MDR, the new European Medical Device Regulation

Investegate announcements from Sequana Medical NV, Sequana Medical receives certification under MDR, the new European Medical Device Regulation

United statesHong kongUnited kingdomCian crosbieTimur reschGuillaume van renterghemCompany or sequanaBritish standards institutionEuropean unionDevice single audit programSequana medicalEuropean medical deviceEuronext brusselsMedical device regulationNotified bodyManagement system

Sequana Medical NV (via Public) / Sequana Medical receives MDSAP certification and expands its Quality Management System towards North America

Sequana Medical NV (via Public) / Sequana Medical receives MDSAP certification and expands its Quality Management System towards North America
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United statesHong kongUnited kingdomCian crosbieTimur reschGuillaume van renterghemBritish standards institutionDrug administrationHealth canadaDevice single audit programSequana medicalEuronext brusselsMedical device single audit programQuality management systemGlobal vice presidentMedical device regulation