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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 NumberS005
Date Received05/13/2026
Decision Date06/11/2026
Product Code PFV 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a duplicate manufacturing line for the Wrapsody Cell-Impermeable Endoprosthesis
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