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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.
Classification Namestent, coronary
Generic Namestent, coronary
1000 park 40 plaza suite 325
durham, NC 27713
PMA NumberP150039
Date Received10/30/2015
Decision Date02/21/2017
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 17M-1121
Notice Date 02/27/2017
Advisory Committee Cardiovascular
Clinical Trials NCT01258972
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the TRYTON Side Branch Stent. This device is indicated for improving the side branch luminal diameter of de novo native coronary artery bifurcation lesions (Medina Classification 1.1.1; 0.1.1; 1.0.1) with a side branch diameter stenosis of >=50% and a lesion length <=5.0 mm, along with reference vessel diameters >=2.5 mm to <=3.5 mm in the side branch and >=2.5 mm to <=4.0 mm in the main branch. The device is intended for use in conjunction with commercially available balloon expandable drug-eluting coronary stents in the main branch.
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 S004