CryoGen's First Option
This article was originally published in The Gray Sheet
Executive Summary
FDA's Obstetrics and Gynecology Devices Panel will meet Jan. 29 to review a July 2000 PMA to expand labeling for the intrauterine cryosurgical probe to include endometrial ablation. First Option received 510(k) clearance in March 1997 for use in dermatology, general surgery, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctology, and urology (1"The Gray Sheet" Feb. 14, 2000, p. 26)