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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 NameFEMSOFT URETHRAL INSERT
Classification Nametransurethral occlusion insert, urinary incontinence-control, female
Generic Nameurethral insert/trethral plug
ApplicantROCHESTER MEDICAL CORP.
PMA NumberP990002
Date Received01/19/1999
Decision Date09/30/1999
Product Code
OCK
Docket Number 99M-4330
Notice Date 10/15/1999
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
The device is indicated for the management of stress urinary incontinence in adult females.
Approval Order Approval Order
Supplements: S001 S002 
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