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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 035 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 NumberS022
Date Received01/25/2018
Decision Date08/29/2018
Product Code ONU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an extension of the product matrix to include balloon lengths up to 220 mm for all diameters of the Lutonix 035 Drug Coated Balloon.
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