Home » DexCom Glucose Sensor PMA Accepted, Granted Expedited Review
DexCom Glucose Sensor PMA Accepted, Granted Expedited Review
May 16, 2005
DexCom announced it has received notification from the FDA that its PMA (premarket approval application) for the DexCom Short-Term Continuous Glucose Sensor submitted in March 2005 has been accepted as filed and granted expedited review status. Having the PMA accepted as filed is the first step in the review process for a PMA and indicates that the FDA considers the PMA sufficiently complete to permit a substantiative review
Genetic Engineering News (http://www.genengnews.com/news/bnitem.aspx?name=527597XSL_NEWSML_TO_NEWSML_WEB.xml)
KEYWORDS FDAnews Device Daily Bulletin
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