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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFEMSOFT URETHRAL INSERT
Generic NameTransurethral occlusion insert, urinary incontinence-control, female
ApplicantROCHESTER MEDICAL CORP.
ONE ROCHESTER MEDICAL DR.
STEWARTVILLE, MN 55976
PMA NumberP990002
Supplement NumberS002
Date Received12/26/2012
Decision Date03/21/2013
Withdrawal Date 09/07/2022
Product Code OCK 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR LABELING MODIFICATIONS.
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