CryoGen On Track For Second Quarter Endometrial Ablation PMA Submission
This article was originally published in The Gray Sheet
Executive Summary
Cryogen plans to file data in support of a premarket approval application during the second quarter to expand labeling for the First Option intrauterine cryosurgical probe to include specific references to endometrial ablation as a treatment for dysfunctional uterine bleeding.
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Panel Favors First Option, Proposes Study To Address Device Malfunctions
CryoGen should conduct a premarket prospective study of the First Option uterine cryoablation therapy to validate changes made in response to reported device malfunctions, FDA's Obstetrics and Gynecology Devices Panel agreed Jan. 29 in recommending an expanded claim for endometrial ablation.
Panel Favors First Option, Proposes Study To Address Device Malfunctions
CryoGen should conduct a premarket prospective study of the First Option uterine cryoablation therapy to validate changes made in response to reported device malfunctions, FDA's Obstetrics and Gynecology Devices Panel agreed Jan. 29 in recommending an expanded claim for endometrial ablation.
CryoGen's First Option
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)