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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.
 
DeviceProACT Adjustable Continence Therapy for Men
Generic NameDevice, incontinence, mechanical/hydraulic
Regulation Number876.5280
ApplicantUromedica, Inc.
1840 Berkshire Ln. N.
Plymouth, MN 55441
PMA NumberP130018
Supplement NumberS006
Date Received01/13/2026
Decision Date02/11/2026
Product Code EZY 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
addition of a post-cure process to the manufacturing procedure for the implantable device component
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