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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
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantLutonix
9409 Science Center Dr.
New Hope, MN 55428
PMA NumberP130024
Supplement NumberS042
Date Received11/18/2021
Decision Date12/02/2021
Product Code ONU 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Removal of a process documentation step for the vacuum drying process when no deviations from process parameters are identified during the automated cycle, to reduce redundancy.
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