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: FC2 FEMALE CONDOM
• Generic Name: Single-use internal condom
• Regulation Number: 884.5340
• Applicant: Veru, Inc.; 4400 Biscayne Blvd; Suite #888; Miami, FL 33137
• PMA Number: P080002
• Date Received: 01/08/2008
• Decision Date: 03/10/2009
• Reclassified Date: 10/29/2018
• Product Code: MBU
• Docket Number: 09M-0159
• Notice Date: 03/25/2009
• Advisory Committee: Obstetrics/Gynecology
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR THE FC2 FEMALE CONDOM. THE DEVICE IS INDICATED FOR PREVENTING PREGNANCY, HIV/AIDS, AND OTHER SEXUALLY TRANSMITTED INFECTIONS (STIS).

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001 S002