InStent EndoCoil biliary stent is awaiting 510(k) clearance -- IPO.
This article was originally published in The Gray Sheet
Executive Summary
INSTENT ENDOCOIL STENT FOR MALIGNANT BILIARY STRICTURES due to pancreatic cancer is awaiting 510(k) clearance by FDA, the firm notes in a registration statement filed with the Securities and Exchange Commission for an initial public offering. The company "has responded to requests from FDA for additional information" on the 510(k) and "is currently awaiting FDA action," the filing states.
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