Cardiac devices; Device approval; Medical devices; Pediatric cardiology
Indexed keywords
BALLOON DILATATION;
BALLOON EMBOLIZATION;
CATHETER;
CLINICAL EVALUATION;
CLINICAL PRACTICE;
CLINICAL TRIAL;
CORONARY STENT;
FOOD AND DRUG ADMINISTRATION;
GROUPS BY AGE;
GUIDE WIRE;
HEART SURGERY;
HIGH RISK PATIENT;
HUMAN;
LAW;
MARKETING;
MEDICAL TECHNOLOGY;
PATIENT MONITORING;
PEDIATRIC CARDIOLOGY;
PERFORMANCE;
PRIORITY JOURNAL;
PROCESSING;
RETRACTOR;
REVIEW;
SAFETY;
SCALPEL;
CARDIAC SURGICAL PROCEDURES;
CARDIOLOGY;
CHILD;
DEVICE APPROVAL;
EQUIPMENT DESIGN;
HEART;
HUMANS;
INFANT, NEWBORN;
PEDIATRICS;
PRODUCT SURVEILLANCE, POSTMARKETING;
REGISTRIES;
THERAPIES, INVESTIGATIONAL;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
YOUNG ADULT;
Application of models for multivariate mixed outcomes to medical device trials: Coronary artery stenting
DOI 10.1002/sim.1337
O'Malley AJ, Normand ST, Kuntz RE. Application of models for multivariate mixed outcomes to medical device trials: coronary artery stenting. Stat Med. 2003;22(2):313-336 (Pubitemid 36163588)
Proposed standards for clinical evaluation of patent ductus arteriosus occlusion devices. Multiorganization Advisory Panel to FDA for Pediatric Cardiovascular Devices
Proposed standards for clinical evaluation of patent ductus arteriosus occlusion devices. Multiorganization Advisory Panel to FDA for Pediatric Cardiovascular Devices. Catheter Cardiovasc Interv. 2000;51(3):293-296