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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 GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
Generic NameAbsorbable coronary drug-eluting stent
ApplicantAbbott Vascular, Inc.
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP150023
Supplement NumberS001
Date Received07/11/2016
Decision Date10/07/2016
Withdrawal Date05/11/2023
Product Code PNY 
Advisory Committee Cardiovascular
Clinical TrialsNCT00856856
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a shelf life extension from 12 months to 18 months for the small scaffold design (2.5 and 3.0mm diameters), and the implementation of an alternate temperature monitoring system.
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