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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 NumberS013
Date Received07/10/2025
Decision Date08/08/2025
Product Code NXW 
Advisory Committee Cardiovascular
Clinical TrialsNCT04227899
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of revisions to the Esprit BTK-PAS – New Enrollment Study protocol (ABT-CIP-10519 Ver. C)
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