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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameRELIANCE URINARY CONTROL INSERT & SIZING DEVICE
Classification Nametransurethral occlusion insert, urinary incontinence-control, female
Generic Nameurological catheters & accessories
ApplicantUROMED CORP.
PMA NumberP960020
Supplement NumberS001
Date Received03/17/1999
Decision Date04/01/1999
Product Code
OCK[ Registered Establishments with OCK ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for suspension of postapproval study because company is discontinuing manufacture and distribution of device.
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