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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.
 
DeviceMICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantMICROSULIS MEDICAL LTD.
PARKLANDS BUSINESS PARK
DENMEAD HAMPSHIRE PO7 6
PMA NumberP020031
Date Received07/24/2002
Decision Date09/23/2003
Withdrawal Date 07/05/2011
Product Code MNB 
Docket Number 04M-0031
Notice Date 01/22/2004
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM. THE DEVICE IS INDICATED FOR ABLATION OF THE ENDOMETRIAL LINING OF THE UTERUS IN PRE-MENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE UTERINE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 
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