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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
Classification Namedrug-eluting peripheral transluminal angioplasty catheter
Generic Namedrug-eluting peripheral transluminal angioplasty catheter
Applicant
LUTONIX
9409 science center dr
new hope, MN 55428
PMA NumberP130024
Date Received11/25/2013
Decision Date10/09/2014
Product Code
ONU[ Registered Establishments with ONU ]
Docket Number 14M-1597
Notice Date 10/14/2014
Advisory Committee Cardiovascular
Clinical Trials NCT00930813
NCT01412541
NCT01628159
NCT01790243
Expedited Review Granted? Yes
Combination Product Yes
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 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 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S017 S018 S020 
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