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Device | MINERVA ENDOMETRIAL ABLATION SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | MINERVA SURGICAL 101 SAGINAW DRIVE REDWOOD CITY, CA 94063 |
PMA Number | P140013 |
Date Received | 07/01/2014 |
Decision Date | 07/27/2015 |
Product Code |
MNB |
Docket Number | 15M-2739 |
Notice Date | 08/27/2015 |
Advisory Committee |
Obstetrics/Gynecology |
Clinical Trials | NCT01569763
|
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 Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S009 S010 S011 S012 S013 S014 S015 |