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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.
 
DeviceLutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)
Generic NameDrug-coated peripheral transluminal angioplasty catheter
ApplicantLutonix
9409 Science Center Dr.
New Hope, MN 55428
PMA NumberP170003
Supplement NumberS016
Date Received01/21/2020
Decision Date04/21/2020
Product Code PRC 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a new colorant in the base catheter and an increase in marker band length for the Lutonix 018 Drug Coated Balloon PTA Catheter.
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