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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.
 
DeviceOmnilink Elite Vascular Balloon-Expandable Stent System
Generic NameSTENT, ILIAC
ApplicantAbbott Vascular-Cardiac Therapies
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP110043
Supplement NumberS015
Date Received12/17/2025
Decision Date01/12/2026
Product Code NIO 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updates to the device Instructions for Use (IFU) and patient guide including updates to the contraindications, warnings, precautions, procedural updates, and MRI Safety information
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