Novasure Impedance Controlled Endometrial Ablation System

FDA premarket approval P010013 · Device, thermal ablation, endometrial

PMA numberP010013

Approval

Applicant
Hologic, Inc.
Received
February 28, 2001
Decision date
September 28, 2001 (APPR)
Supplements
86, latest December 17, 2025
Product code
MNB – Device, Thermal Ablation, Endometrial

Official FDA PMA record

Approval order statement

APPROVAL FOR THE NOVASURE(TM) IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM. THE DEVICE IS INTENDED TO ABLATE THE ENDOMETRIAL LINING OF THE UTERUS OF PRE-MENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE.