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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 018 Drug Coated Balloon PTA Catheters
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantLUTONIX
9409 SCIENCE CENTER DR
NEW HOPE, MN 55428
PMA NumberP130024
Supplement NumberS032
Date Received11/25/2019
Decision Date12/18/2019
Product Code ONU 
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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