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Medical technology / Cardiology / Prosthetics / AbioMed / Medical device / Cannula / Cardiac output / Circulatory system / IEC 60601 / Medicine / Medical equipment / Implants


Summary Basis of Decision AB5000 Circulatory Support System
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Document Date: 2013-07-12 14:26:14


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Company

CIRCULATORY SUPPORT SYSTEM ABIOMED Inc. / Circulatory Support System Manufacturer ABIOMED Inc. / Health Canada ABIOMED Inc. / FOREWORD Health Canada / ABIOMED Inc. / No. 69475 2 Health Canada ABIOMED Inc. / Licence No. 69475 Health Canada ABIOMED Inc. / /

Continent

Europe / /

Country

United States / Canada / Australia / Lebanon / /

Event

FDA Phase / /

IndustryTerm

software algorithm / Subsequent applications / particular product / Risk management / electrical equipment / software verification / food / /

MedicalCondition

acute cardiac disorders / stroke / interstitial pulmonary hemorrhage / low cardiac output / air embolism / reversible ventricular dysfunction / /

MedicalTreatment

cardiac surgery / bypass / cannulation / cannula / embolization / /

Organization

Federal Aviation Administration / Health Products and Food Branch / Marketed Health Products Directorate / /

Position

surgeon / General / /

Product

AB5000 / SBD / /

PublishedMedium

the Health Canada review / /

Technology

software algorithm / /

URL

http /

SocialTag