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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.
 
DeviceWomed Leaf Resorbable Adhesion Barrier
Generic NameBarrier, absorbable, adhesion
ApplicantWomed Sas
Batiment Balard Cit
1919 Rte. De Mende
Montpellier 34090
PMA NumberP240015
Date Received05/10/2024
Decision Date09/09/2025
Product Code MCN 
Advisory Committee Obstetrics/Gynecology
Clinical TrialsNCT04381728
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Womed Leaf® Resorbable Adhesion Barrier is intended to reduce the reoccurrence and severity of post-surgical adhesion formation inside the uterus. It is indicated for adult women undergoing hysteroscopic surgery for symptomatic moderate to severe intrauterine adhesions.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 
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