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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 NumberS010
Date Received12/16/2020
Decision Date10/28/2021
Product Code ONU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Philips Image Guided Therapy Devices, 5905 Nathan Lane North, Plymouth, MN for a site change of the analytical laboratory for stability testing of Stellarex 0.035” Drug Coated Angioplasty Balloon.
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