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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
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
Supplement NumberS009
Date Received01/04/2016
Decision Date02/07/2017
Product Code
ONU[ Registered Establishments with ONU ]
Docket Number 17M-0831
Notice Date 02/15/2017
Advisory Committee Cardiovascular
Clinical Trials NCT01864278
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for Lutonix DCB is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions up to 300 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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