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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 NumberS007
Date Received03/13/2017
Decision Date08/07/2017
Withdrawal Date05/11/2023
Product Code PNY 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to change the finished goods molecular weight testing sampling plan and molecular weight stability testing plan.
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