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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 NumberS020
Date Received08/25/2026
Decision Date09/24/2026
Product Code NXW 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
addition of in-process scaffold dimensional inspections for the Esprit BTK LL System
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