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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.
Classification Nametransurethral occlusion insert, urinary incontinence-control, female
Generic Nametransurethral occlusion insert, urinary incontinence-control, female
one rochester medical dr.
stewartville, MN 55976
PMA NumberP990002
Date Received01/19/1999
Decision Date09/30/1999
Product Code
OCK[ Registered Establishments with OCK ]
Docket Number 99M-4330
Notice Date 10/15/1999
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
The device is indicated for the management of stress urinary incontinence in adult females.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002