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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 NumberS004
Date Received01/23/2019
Decision Date10/11/2019
Product Code ONU 
Advisory Committee Cardiovascular
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  
Approval for 150 mm and 200 mm balloon lengths for the Stellarex 0.035 OTW Drug-coated Angioplasty Balloon.
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