Premarket Approval (PMA)

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.

• Device: Optilume Urethral Drug Coated Balloon
• Generic Name: Catheter, Balloon, Urethral, Drug-Coated
• Applicant: Urotronic, Inc.; 2495 Xenium Ln.; Minneapolis, MN 55441
• PMA Number: P210020
• Supplement Number: S006
• Date Received: 08/30/2022
• Decision Date: 09/29/2022
• Product Code: QRH
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.