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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 NumberS006
Date Received08/01/2024
Decision Date08/28/2024
Product Code NXW 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a change to the sampling plan for finished device in vitro engineering lot release and analytical lot release testing
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