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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 NumberS001
Date Received12/14/2000
Decision Date12/28/2000
Withdrawal Date 09/07/2022
Product Code OCK 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO ADD THE PRECAUTION "AVOID HEAT" TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FEMSOFT(R) INSERT AND IS INDICATED FOR THE MANAGEMENT OF STRESS URINARY INCONTINENCE IN ADULT FEMALES.
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