Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NumberS004
Date Received09/03/2025
Decision Date10/03/2025
Product Code EZY 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the modifications to the study protocol including expansion of the study to 10-14 study sites and modifications to the Informed Consent Form for the post-approval study.
-
-