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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 Drug Coated Ballon Percutaneous Transluminal Angioplasty Catheter
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantThe Spectranetics Corp.
6531 Dumbarton Cir.
Fremont, CA 94555
PMA NumberP160049
Supplement NumberS018
Date Received04/01/2022
Decision Date06/22/2022
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 Corporation, 5905 Nathan Lane North, Plymouth, MN 55442 for catheter assembly of the Stellarex 035 Drug Coated Balloon.
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