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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.
 
DeviceRELIANCE URINARY CONTROL INSERT AND SIZING DEVICE
Classification Nametransurethral occlusion insert, urinary incontinence-control, female
Generic Nametransurethral occlusion insert, urinary incontinence-control, female
Applicant
UROMED CORP.
64 a st.
needham, MA 02194
PMA NumberP960020
Date Received08/18/1995
Decision Date08/16/1996
Product Code
OCK[ Registered Establishments with OCK ]
Docket Number 96M-0447
Notice Date 12/02/1996
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
APPROVAL FOR THE RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE
Supplements: S001 
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