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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 NumberS024
Date Received06/25/2018
Decision Date09/10/2018
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 a change to the balloon wall thickness for the 6 x 220 mm and 7 x 80 - 220 mm balloon sizes as well as a reduction in the labeled introducer sheath compatibility of these device sizes.
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