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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 035 OTW Drug-Coated Angiopiasty Balloon (DCB)
Generic Namedrug-eluting peripheral transluminal angioplasty catheter
ApplicantThe Spectranetics Corp.
6531 dumbarton circle
fremont, CA 94555
PMA NumberP160049
Supplement NumberS011
Date Received01/21/2021
Decision Date02/19/2021
Product Code ONU 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Addition of sterilization chamber 4 in the Los Angeles, CA sterilization facility.