Premarket Approval (PMA)

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 Name: F C FEMALE CONDOM
• Classification Name: condom, female, single-use
• Generic Name: female condom
• Regulation Number: 884.5330
• Applicant: THE FEMALE HEALTH CO.
• PMA Number: P910064
• Date Received: 10/29/1991
• Decision Date: 05/07/1993
• Withdrawal Date: 09/01/2010
• Product Code: MBU [ Registered Establishments with MBU ]
• Docket Number: 93M-0186
• Notice Date: 09/01/1993
• Advisory Committee: Obstetrics/Gynecology
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001 S002 S003 S004 S005 S006 ; S007 S008 S009 S010 S011 S012 ; S013