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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.
 
DeviceSTELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantThe Spectranetics Corp.
6531 Dumbarton Circle
Fremont, CA 94555
PMA NumberP160049
Date Received11/02/2016
Decision Date07/26/2017
Product Code ONU 
Docket Number 17M-4498
Notice Date 07/28/2017
Advisory Committee Cardiovascular
Clinical TrialsNCT01858428
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval of the Stellarex 0.035 OTW Drug-coated Angioplasty Balloon. This device is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 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 S004 S005 S006 S007 S008 S010 S011 S012 
S013 S015 S017 S018 S019 S020 S021 S022 S023 
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