Premarket Approval (PMA)

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.

• Device: FEMSOFT URETHRAL INSERT
• Generic Name: Transurethral occlusion insert, urinary incontinence-control, female
• Applicant: ROCHESTER MEDICAL CORP.; ONE ROCHESTER MEDICAL DR.; STEWARTVILLE, MN 55976
• PMA Number: P990002
• Date Received: 01/19/1999
• Decision Date: 09/30/1999
• Withdrawal Date: 09/07/2022
• Product Code: 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