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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
Generic NameCatheter, Balloon, Urethral, Drug-Coated
ApplicantUrotronic, Inc.
2495 Xenium Ln.
Minneapolis, MN 55441
PMA NumberP210020
Supplement NumberS004
Date Received02/24/2022
Decision Date05/17/2022
Product Code QRH 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for validation of a new Low EO sterilization cycle utilizing a lower ethylene oxide (EO) concentration and lower EO dwell time.
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