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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.
 
DeviceOptilume Urethral Drug Coated Balloon catheter
Generic NameCatheter, Balloon, Urethral, Drug-Coated
ApplicantUrotronic, Inc.
2495 Xenium Ln.
Minneapolis, MN 55441
PMA NumberP210020
Supplement NumberS009
Date Received12/08/2023
Decision Date01/13/2024
Product Code QRH 
Advisory Committee Gastroenterology/Urology
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  
to implement an additional Confluent Medical catheter manufacturing site in Costa Rica
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