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  /  Part II.1 – Regulatory Pathway for 510k, IDE, and PMA
  II.1 Regulatory Pathway for 510k, IDE, and PMA Deborah G Castillo PhD, Bram Zuckerman MD and Felipe Aguel PhD A. Introduction The premarket regulatory framework for cardiovascular devices differs from the premarket processes for cardiovascular drug and biological products. Perhaps the biggest reason for this is […]