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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 circle
fremont, CA 94555
PMA NumberP160049
Supplement NumberS012
Date Received05/07/2021
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
Approval Order Statement  
Approval for a manufacturing site located at Philips Image Guided Therapy Corporation, 5905 Nathan Lane North Plymouth, MN 55442, for manufacturing, including finished lot release testing and finished product testing, for the Stellarex 035 Drug Coated balloon.