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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceWRAPSODY® Cell-Impermeable Endoprosthesis
Generic NameSystem, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
ApplicantMerit Medical Systems, Inc.
1600 W. Merit Pkwy.
South Jordan, UT 84095
PMA NumberP240023
Supplement NumberS004
Date Received11/14/2025
Decision Date12/11/2025
Product Code PFV 
Advisory Committee Cardiovascular
Clinical TrialsNCT06807099
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240023
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