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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceEsprit™ BTK Everolimus Eluting Resorbable Scaffold System
Generic NameScaffold, infrapopliteal, absorbable
ApplicantAbbott Medical
3200 Lakeside Dr.
S,Mta Clara, CA 95054
PMA NumberP230036
Date Received10/31/2023
Decision Date04/26/2024
Product Code NXW 
Docket Number 24M-2122
Notice Date 05/06/2024
Advisory Committee Cardiovascular
Clinical TrialsNCT04227899
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Esprit™ BTK Everolimus Eluting Resorbable Scaffold System is indicated for improving luminal diameter in infrapopliteal lesions in patients with Chronic Limb Threatening Ischemia (CLTI) and total scaffolding length up to 170 mm with a reference vessel diameter of >= 2.5 mm and <= 4.00 mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 
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