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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 NumberS022
Date Received11/06/2023
Decision Date12/05/2023
Product Code ONU 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to change the location of the supplier for extruded mono-lumen and multi-lumen material and changes to the associated material receiving inspection procedures
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