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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.
 
DeviceAbsorb GTi Bioresorbable Vascular Scaffold (BVS) System
Generic NameAbsorbable coronary drug-eluting stent
ApplicantABBOTT VASCULAR INC.
3200 Lakeside Drive
Santa Clara, CA 95054
PMA NumberP150023
Supplement NumberS009
Date Received05/17/2017
Decision Date06/23/2017
Withdrawal Date 05/11/2023
Product Code PNY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Extend the retest period from 60 months to 96 months for everolimus repackaged in Configuration I.
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