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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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