US FDA perspective on regulatory issues affecting circulatory assist devices

Expert Review of Medical Devices

Volumn 3, Issue 6, 2006, Pages 749-753

  Sapirstein, Wolf ^a   Chen, Eric ^a   Swain, Julie ^a   Zuckerman, Bram ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

Bridge to transplant; End stage heart failure; Mechanical circulatory assist; Regulatory procedures; Ventricular assist devices

Indexed keywords

ANTITHROMBOCYTIC AGENT; THROMBIN INHIBITOR;

AORTA BALLOON; ARTICLE; ASSISTED CIRCULATION; ASSISTIVE TECHNOLOGY DEVICE; BRAIN HEMORRHAGE; BRAIN INJURY; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; DEVICE INFECTION; EMBOLISM; FOOD AND DRUG ADMINISTRATION; HEALTH CARE QUALITY; HEART FAILURE; HEART FUNCTION; HEART TRANSPLANTATION; HOMEOSTASIS; HUMAN; SAFETY; SEPSIS; THROMBOCYTE AGGREGATION; THROMBOELASTOGRAPHY; UNITED STATES; VASCULAR ACCESS DEVICE;

DEVICE APPROVAL; GUIDELINES; HEART-ASSIST DEVICES; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33845870402     PISSN: 17434440     EISSN: 17452422     Source Type: Journal    
DOI: 10.1586/17434440.3.6.749     Document Type: Article

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