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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
Classification Nameabsorbable coronary drug-eluting stent
Generic Nameabsorbable coronary drug-eluting stent
Applicant
ABBOTT VASCULAR INC.
3200 lakeside drive
santa clara, CA 95054
PMA NumberP150023
Supplement NumberS010
Date Received03/01/2018
Decision Date05/30/2018
Product Code
PNY[ Registered Establishments with PNY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for implementation of everolimus BHT manufactured at a new manufacturing site.
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