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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 0.035 OTW Drug-Coated Angioplasty Balloon
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantThe Spectranetics Corp.
6531 Dumbarton Cir.
Fremont, CA 94555
PMA NumberP160049
Supplement NumberS027
Date Received08/29/2025
Decision Date11/24/2025
Product Code ONU 
Advisory Committee Cardiovascular
Clinical TrialsNCT01858428
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
for the implementation of an alternative paclitaxel active pharmaceutical ingredient utilized in the drug coating of the Stellarex 0.035" OTW Drug-coated Angioplasty Balloon
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