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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 DCB)
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantLutonix
9409 Science Center Dr.
New Hope, MN 55428
PMA NumberP130024
Supplement NumberS027
Date Received02/26/2019
Decision Date05/23/2019
Product Code ONU 
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 the addition of 80, 100, 120, 150 and 220 mm balloon size lengths to the 7 mm diameter balloon on a .018 guidewire compatible catheter (Lutonix 018).
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