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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
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantLutonix
9409 Science Center Dr.
New Hope, MN 55428
PMA NumberP130024
Supplement NumberS005
Date Received06/02/2015
Decision Date11/20/2015
Product Code ONU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE 7 X 40 MM AND 7 X 60 MM DEVICE SIZES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LUTONIX 035 DRUG COATED BALLOON PTA CATHETER AND 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 VESSEL DIAMETERS OF 4-7 MM.
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