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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 DRUG COATED BALLOON PTA CATETER
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantLUTONIX
9409 SCIENCE CENTER DR
NEW HOPE, MN 55428
PMA NumberP130024
Date Received11/25/2013
Decision Date10/09/2014
Product Code ONU 
Docket Number 14M-1597
Notice Date 10/14/2014
Advisory Committee Cardiovascular
Clinical TrialsNCT00930813
Expedited Review Granted? Yes
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (LUTONIX DCB). THIS DEVICE IS INDICATED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, AFTER PRE-DILATATION, OF DE NOVO OR RESTENOTIC LESIONS UP TO 150MM IN LENGTH IN NATIVE SUPERFICIAL FEMORAL OR POPLITEAL ARTERIES WITH REFERENCE VESSELDIAMETERS OF 4-6MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S002 S005 S009 S010 S012 S014 S017 S006 S003 S004 S001 
S007 S011 S013 S018 S015 S022 S024 S020 S033 S026 S035 S036 
S040 S023 S021 S032 S037 S029 S030 S031 S034 S025 S027 S038 
S043 S042 S041 S008 
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