www.fdanews.com/articles/69212-conceptus-submits-pma-supplement-to-support-essure-effectiveness
Conceptus Submits PMA Supplement to Support Essure Effectiveness
February 25, 2005
Conceptus, developer of the nonincisional permanent birth control procedure Essure, announced that it has submitted a premarket approval (PMA) supplement to the FDA to extend effectiveness data on the Essure product labeling. The supplemental filing supports an extension of the effectiveness of Essure to four and five years of follow-up and is expected to be unchanged from the 99.8 percent effectiveness rate for one, two and three years of follow-up.