title: Cardiovascular devices; reclassification of external counter-pulsating devices for treatment of chronic stable angina; effective date of requirement for premarket approval for external counter-pulsating devices for other specified intended uses. Final order.
abstract: The Food and Drug Administration (FDA) is issuing a final order to reclassify external counter-pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization, which is a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for ECP devices for other intended uses specified in this proposed order.
mesh_terms: D000787:Angina Pectoris / Q000628:therapy; D002908:Chronic Disease; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification*; D006353:Heart-Assist Devices / Q000145:classification*; D006801:Humans; D014481:United States