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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-coated peripheral transluminal angioplasty catheter
ApplicantLUTONIX
9409 Science Center Drive
New Hope, MN 55428
PMA NumberP170003
Supplement NumberS015
Date Received11/25/2019
Decision Date12/18/2019
Product Code PRC 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Implement a minor change affecting the hub component of drug coated balloon catheter.
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