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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.
 
DeviceAbre Venous Self-expanding Stent System
Generic NameStent, iliac vein
ApplicantMedtronic Vascular, Inc.
3033 Campus Dr.
Plymouth, MN 55441
PMA NumberP200026
Supplement NumberS005
Date Received06/17/2022
Decision Date07/22/2022
Product Code QAN 
Advisory Committee Cardiovascular
Clinical TrialsNCT03038438
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updates to the labeling to include long-term results from the ABRE Continued Follow-Up Study.
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