Minerva Endometrial Ablation System

FDA premarket approval P140013 · Device, thermal ablation, endometrial

PMA numberP140013

Approval

Applicant
Axora Medical, Inc.
Received
July 1, 2014
Decision date
July 27, 2015 (APPR)
Supplements
17, latest February 12, 2026
Product code
MNB – Device, Thermal Ablation, Endometrial

Official FDA PMA record

Approval order statement

APPROVAL FOR THE MINERVA ENDOMETRIAL ABLATION SYSTEM. THIS DEVICE IS INDICATED FOR ABLATION OF THE ENDOMETRIAL LINING OF THE UTERUS IN PRE-MENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE.