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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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
Date Received07/01/2015
Decision Date07/05/2016
Product Code
PNY[ Registered Establishments with PNY ]
Docket Number 16M-1914
Notice Date 07/21/2016
Advisory Committee Cardiovascular
Clinical Trials NCT00856856
NCT01425281
NCT01751906
NCT01844284
NCT02173379
NCT02229864
Expedited Review Granted? No
Combination Product Yes
Recalls CDRH Recalls
Approval Order Statement 
Approval for the ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) System. This device is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions >=2.5 mm to <=3.75 mm in diameter in lesions <=24 mm in length.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S005 S006 S007 S008 S009 
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