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: F C FEMALE CONDOM
• Generic Name: Single-use internal condom
• Regulation Number: 884.5340
• Applicant: THE FEMALE HEALTH CO.; 515 NORTH STATE ST.; SUITE 2225; CHICAGO, IL 60654
• PMA Number: P910064
• Date Received: 10/29/1991
• Decision Date: 05/07/1993
• Withdrawal Date: 09/01/2010
• Product Code: MBU
• Docket Number: 93M-0186
• Notice Date: 09/01/1993
• Advisory Committee: Obstetrics/Gynecology
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S012 S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 ; S011 S013