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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 NumberS001
Date Received12/21/2015
Decision Date11/02/2016
Product Code EZY 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the protocol for the post-approval study protocol.
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