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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceLUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010
Classification Namedrug-coated peripheral transluminal angioplasty catheter
Generic Namedrug-coated peripheral transluminal angioplasty catheter
9409 science center drive
new hope, MN 55428
PMA NumberP170003
Date Received01/23/2017
Decision Date08/25/2017
Product Code
PRC[ Registered Establishments with PRC ]
Docket Number 17M-5334
Notice Date 09/08/2017
Advisory Committee Cardiovascular
Clinical Trials NCT02440022
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the LUTONIX® 035 Drug Coated Balloon PTA Catheter. This device is indicated for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of stenotic lesions in dysfunctional native arteriovenous dialysis fistulae that are 4 mm to 12 mm in diameter and up to 80 mm in length.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S006 S007 S008 S012