Conceptus' STOP
This article was originally published in The Gray Sheet
Executive Summary
Selective tubal occlusion procedure system premarket approval application submission to FDA is slated for the third quarter of 2002. Bilateral placement of the non-surgical permanent contraception device has been achieved in more than 400 patients in a clinical study, the firm reports Jan. 3. Trial protocol requires 12 months of follow-up after each patient begins to rely exclusively on the device for contraception, which occurs three months following the placement procedure