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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceStellarex 0.035OTW Drug-coated Angioplasty Balloon
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantThe Spectranetics Corp.
6531 Dumbarton Circle
Fremont, CA 94555
PMA NumberP160049
Supplement NumberS015
Date Received09/29/2021
Decision Date03/25/2022
Product Code ONU 
Docket Number 22M-1917
Notice Date 08/23/2022
Advisory Committee Cardiovascular
Clinical TrialsNCT01927068
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for The Stellarex 0.035 inch OTW Drug-coated Angioplasty Balloon. The Stellarex 0.035 inch OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions up to 180 mm in length in superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2