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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.
 
DeviceESSURE SYSTEM
Generic NameTranscervical contraceptive tubal occlusion device
Regulation Number884.5380
ApplicantBAYER PHARMA AG
MOLLERSTRABE 178
BERLIN 13353
PMA NumberP020014
Date Received04/22/2002
Decision Date11/04/2002
Product Code HHS 
Docket Number 03M-0175
Notice Date 04/28/2003
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ESSURE SYSTEM. THE DEVICE IS INDICATED FOR PERMANENT BIRTH CONTROL (FEMALE STERILIZATION) BY BILATERAL OCCLUSION OF THE FALLOPIAN TUBES.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S012 
S013 S014 S015 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S029 S030 S032 S033 S034 S035 S036 S037 S038 S039 
S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 
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