Circulatory System Devices Panel.
This article was originally published in The Gray Sheet
Premarket approval application for a hemodialysis vascular access graft is scheduled for review on April 23 in Gaithersburg, Maryland. The panel will make same-day recommendations to FDA on preclinical and clinical data requirements for devices intended for use as adjuncts to the Heimlich maneuver. On April 24, a PMA for PLC Systems' Heart Laser for transmyocardial revascularization will be reviewed. The panel voted against approval following a previous panel review of the PMA in July ("The Gray Sheet" Aug. 4, 1997, p. 7)...
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