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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.
 
DeviceORSIRO Sirolimus Eluting Coronary Stent System
Generic NameCoronary drug-eluting stent
ApplicantBiotronik, Inc
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP170030
Date Received09/27/2017
Decision Date02/22/2019
Product Code NIQ 
Docket Number 19M-0885
Notice Date 02/25/2019
Advisory Committee Cardiovascular
Clinical TrialsNCT02389946
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval of the Orsiro Sirolimus Eluting Coronary Stent System. This device is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm and a lesion length of < 36 mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S015 S023 S019 S020 S014 S028 S029  S006 
S004 S005 S010 S011 S012 S013 S007 S008 S021 S017 S027 S024 
S025 S026 S016 S022 S018 S036 S037 S030 S031 S032 S033 S034 
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