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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.
 
DeviceEsprit™ BTK Everolimus Eluting Resorbable Scaffold System
Generic NameScaffold, infrapopliteal, absorbable
ApplicantABBOTT MEDICAL
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP230036
Supplement NumberS017
Date Received04/01/2026
Decision Date07/09/2026
Product Code NXW 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the addition of a Long Length (LL) scaffold version
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