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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
Generic NameDrug-coated peripheral transluminal angioplasty catheter
ApplicantLutonix
9409 Science Center Dr.
New Hope, MN 55428
PMA NumberP170003
Supplement NumberS011
Date Received09/11/2019
Decision Date12/09/2019
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 an extension to the device balloon size matrix (7.0, and 8.0 mm diameters in 80 and 100 mm lengths, 9.0 mm diameter in 80 mm length and 12.0 mm diameter available in 60 mm length) and a reduction in the cone angle for the 8 through 12 mm diameter balloons to accommodate a reduction in sheath compatibility.
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