Medstone STS Lithotripter Approvable For Gallstone Treatment - FDA Panel
This article was originally published in The Gray Sheet
Medstone International should conduct post-approval studies of its STS lithotripter in combination with Novartis' Actigall (ursodiol) anti-gallstone drug to fragment biliary stones, FDA's Gastroenterology and Urology Devices Panel recommended April 30.
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Medstone International is developing a protocol for a post-approval clinical study of the firm's STS lithotripter for gallstone treatment as FDA begins to revisit its August 1998 decision to reject the firm's premarket approval application.
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