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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameRELIANCE URINARY CONTROL INSERT AND SIZING DEVICE
Classification Nametransurethral occlusion insert, urinary incontinence-control, female
Generic Nameurological catheters & accessories
ApplicantUROMED CORP.
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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