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Cardiology / Medical technology / Artificial heart / Medical device / Medtronic / Food and Drug Administration / Electrical engineering / Electromagnetic interference / Medicine / Technology / Implants


Summary Basis of Decision (SBD) CardioWest C70 Temporary Artificial Heart
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Document Date: 2013-07-12 14:26:22


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File Size: 39,06 KB

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Company

Medtronic / C70 Temporary Total Artificial Heart Manufacturer SynCardia Systems Inc. / Licence No. 69607 Health Canada SynCardia Systems Inc. / FOREWORD Health Canada / EMC / No. 69607 2 Health Canada SynCardia Systems Inc. / Health Canada SynCardia Systems Inc. / SynCardia Systems Inc. / /

Country

Canada / /

Event

FDA Phase / /

Facility

Terminal Units / /

IndustryTerm

Subsequent applications / particular product / software verification / implantable device / food / manufacturing process / /

MedicalCondition

maximum dynamic stroke / dynamic stroke / sterility / pulmonary circulation / pulmonary artery outflow cannula / infection / low cardiac output / pulmonary artery / /

MedicalTreatment

cannula / surgery / /

Organization

Health Products and Food Branch / FDA / British Standards Institution / /

Position

operating physician / General / controller / /

Product

C70 / SBD / /

PublishedMedium

the Health Canada review / /

Technology

artificial intelligence / Information Technology / Radio Frequency / transplantation / /

URL

http /

SocialTag