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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 NumberS003
Date Received08/05/2016
Decision Date10/10/2017
Product Code
PNY[ Registered Establishments with PNY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for your premarket approval application (PMA) request that we place your study on hold.
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