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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMINERVA ENDOMETRIAL ABLATION SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namedevice, thermal ablation, endometrial
Applicant
MINERVA SURGICAL
101 saginaw drive
redwood city, CA 94063
PMA NumberP140013
Date Received07/01/2014
Decision Date07/27/2015
Product Code
MNB[ Registered Establishments with MNB ]
Docket Number 15M-2739
Notice Date 08/27/2015
Advisory Committee Obstetrics/Gynecology
Clinical Trials NCT01569763
NCT02023801
NCT02029911
NCT02035332
Expedited Review Granted? No
Combination Product No
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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 
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