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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 NumberS006
Date Received07/13/2015
Decision Date01/29/2016
Product Code ONU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:CHANGE IN STUDY DESIGN, PRIMARY EFFECTIVENESS COMPARATOR AND PRIMARY SAFETY COMPARATOR.
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