title: Cardiovascular devices; reclassification of intra-aortic balloon and control systems for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure; effective date of requirement for premarket approval for intra-aortic balloon and control systems for septic shock or pulsatile flow generation. Final order.
abstract: The Food and Drug Administration (FDA) is issuing a final order to reclassify intra-aortic balloon and control system (IABP) devices when indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure, 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 IABPs when indicated for septic shock or pulsatile flow generation.
mesh_terms: D054058:Acute Coronary Syndrome / Q000601:surgery; D006348:Cardiac Surgical Procedures / Q000145:classification / Q000295:instrumentation*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification*; D006333:Heart Failure / Q000601:surgery; D006801:Humans; D007423:Intra-Aortic Balloon Pumping / Q000145:classification / Q000295:instrumentation*; D011673:Pulsatile Flow; D012772:Shock, Septic / Q000601:surgery; D014481:United States