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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameESSURE SYSTEM
Classification Nameinsert, tubal occlusion
Generic Namedevice, occlusion, tubal, contraceptive
Regulation Number884.5380
ApplicantCONCEPTUS, INC.
PMA NumberP020014
Date Received04/22/2002
Decision Date11/04/2002
Product Code
HHS[ Registered Establishments with HHS ]
Docket Number 03M-0175
Notice Date 04/28/2003
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
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 
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