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BIONX IMPLANTS' SR-PGA RESORBABLE UROLOGY STENT MARKETING SUBMISSION EXPECTED LATER THIS YEAR; DEVICE IS FIRST RESORBABLE STENT FOR UROLOGIC USE

This article was originally published in The Gray Sheet

Executive Summary

Bionx Implants is planning to submit a marketing application for its SR-PGA resorbable urology stent to FDA later this year, the company says in a preliminary prospectus for an initial public offering filed with the Securities and Exchange Commission on March 13. Bionx has not yet determined whether FDA will require a premarket approval application or a 510(k) for the device.
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