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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
Classification Namedrug-eluting peripheral transluminal angioplasty catheter
Generic Namedrug-eluting peripheral transluminal angioplasty catheter
Applicant
The Spectranetics Corp.
6531 dumbarton circle
fremont, CA 94555
PMA NumberP160049
Date Received11/02/2016
Decision Date07/26/2017
Product Code
ONU[ Registered Establishments with ONU ]
Docket Number 17M-4498
Notice Date 07/28/2017
Advisory Committee Cardiovascular
Clinical Trials NCT01858428
Expedited Review Granted? No
Combination Product Yes
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 
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