Standardization and substantial equivalence of components in antiarrhythmic device systems: a necessity to avoid regulatory gridlock?
Saksena
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Arrhythmia & Pacemaker Service, Eastern Heart Institute, Passaic, New Jersey, USA.
Nickelson
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D001145:Arrhythmias, Cardiac / Q000628:therapy*; D014487:Centers for Medicare and Medicaid Services, U.S.; D003245:Consensus Statements as Topic; D017147:Defibrillators, Implantable / Q000592:standards*; D006801:Humans; D010138:Pacemaker, Artificial / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration