In Brief: Cryomedical Sciences
This article was originally published in The Gray Sheet
Executive Summary
Cryomedical Sciences: Gains 510(k) clearance for its CMS Urethral Warmer System, an accessory to its AccuProbe cryosurgical system. After an original determination that the warmer needed review via premarket approval application, FDA allowed Rockville, Maryland-based CMS to submit a 510(k) for the device in early 1994, provided that the company met certain conditions including submission of clinical data ("The Gray Sheet" Feb. 14, 1994, In Brief)...