NCDR National Cardiovascular Data Registry
NSE not substantially equivalent
PMA premarket approval
QSR quality system review
SSED Summary of Safety and Effectiveness Data
UDI unique device identification
VA US Department of Veterans Affairs
VHA Veterans Health Administration
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Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report . Washington, DC: The National Academies Press,
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