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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
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Applicant
Biotronik, Inc
6024 jean road
lake oswego, OR 97035
PMA NumberP170030
Date Received09/27/2017
Decision Date02/22/2019
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 19M-0885
Notice Date 02/25/2019
Advisory Committee Cardiovascular
Clinical Trials NCT02389946
Expedited Review Granted? No
Combination Product Yes
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S003 
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