Celsion catheters back on the market
This article was originally published in The Gray Sheet
Executive Summary
Columbia, Md.-based Celsion Corporation resumes shipments of its Prolieve thermodilation disposable catheter system to distributor Boston Scientific, following expedited FDA approval Aug. 11 of a PMA supplement requesting changes to its manufacturing and inspection processes. The Prolieve system, which is used to treat prostate cancer, was taken off the market May 4 due to a Class II recall of 2,930 kits...