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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
Generic NameDevice, incontinence, mechanical/hydraulic
Regulation Number876.5280
ApplicantUROMEDICA INC
1840 BERKSHIRE LANE N
PLYMOUTH, MN 55441
PMA NumberP130018
Date Received06/17/2013
Decision Date11/24/2015
Product Code EZY 
Docket Number 15M-4473
Notice Date 02/27/2017
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT00277095
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN. THIS DEVICE IS INDICATED FOR THE TREATMENT OF ADULT MEN WHO HAVE STRESS INCONTINENCE ARISING FROM INTRINSIC SPHINCTER DEFICIENCY OF AT LEAST TWELVE MONTHS DURATION FOLLOWING RADICAL PROSTATECTOMY OR TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) AND WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE THERAPY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 
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