Premarket clinical evaluation of novel cardiovascular devices: Quality analysis of premarket clinical studies submitted to the food and drug administration 2000-2007

American Journal of Therapeutics

Volumn 17, Issue 1, 2010, Pages 2-7

  Kramer, Daniel B ^a   Mallis, Elias ^b   Zuckerman, Bram D ^b   Zimmerman, Barbara A ^b   Maisel, William H ^a  

^a BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

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

Author keywords

Cardiovascular; Clinical trials; Medical device; Regulatory affairs

Indexed keywords

ADULT; AGED; ARTICLE; CARDIOVASCULAR EQUIPMENT; CLINICAL EVALUATION; COMORBIDITY; CONTROLLED STUDY; CORONARY ARTERY DISEASE; DIABETES MELLITUS; FEMALE; FOOD AND DRUG ADMINISTRATION; HEART FAILURE; HUMAN; HYPERTENSION; IMPLANT; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; QUALITY CONTROL; RACE DIFFERENCE; RECIPIENT; SAFETY; SMOKING; THERAPY EFFECT;

ADOLESCENT; ADULT; AGE FACTORS; AGED; BIAS (EPIDEMIOLOGY); CARDIOVASCULAR DISEASES; CLINICAL TRIALS AS TOPIC; DEVICE APPROVAL; ENDPOINT DETERMINATION; EQUIPMENT AND SUPPLIES; EQUIPMENT SAFETY; FEMALE; HUMANS; MALE; MIDDLE AGED; PATIENT SELECTION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; YOUNG ADULT;

EID: 76149099323     PISSN: 10752765     EISSN: None     Source Type: Journal    
DOI: 10.1097/MJT.0b013e3181ca8105     Document Type: Article

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