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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.
 
DeviceWRAPSODY® Cell-Impermeable Endoprosthesis
Generic NameSystem, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
ApplicantMerit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
PMA NumberP240023
Date Received06/26/2024
Decision Date12/19/2024
Product Code PFV 
Docket Number 24M-5932
Notice Date 01/10/2025
Advisory Committee Cardiovascular
Clinical TrialsNCT03644017
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for Merit Medical Systems, Inc. WRAPSODY Cell-Impermeable Endoprosthesis. This device is indicated for use in hemodialysis patients for the treatment of stenosis or occlusion within the dialysis access outflow circuit, including stenosis or occlusion in the peripheral veins of individuals with an arteriovenous (AV) fistula or at the venous anastomosis of a synthetic AV graft.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 
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