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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 NumberS001
Date Received07/11/2016
Decision Date10/07/2016
Product Code
PNY[ Registered Establishments with PNY ]
Advisory Committee Cardiovascular
Clinical Trials NCT00856856
NCT01425281
NCT01751906
NCT01844284
NCT02173379
NCT02229864
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
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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