FC2 FEMALE CONDOM

Single-use Internal Condom

FDA Premarket Approval P080002

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.

Pre-market Approval Supplement Details

Approval for the fc2 female condom. The device is indicated for preventing pregnancy, hiv/aids, and other sexually transmitted infections (stis).

• Device: FC2 FEMALE CONDOM
• Classification Name: Single-use Internal Condom
• Generic Name: Single-use Internal Condom
• Applicant: Veru, Inc.
• Date Received: 2008-01-08
• Decision Date: 2009-03-10
• Notice Date: 2009-03-25
• PMA: P080002
• Supplement: S
• Product Code: MBU
• Docket Number: 09M-0159
• Advisory Committee: Obstetrics/Gynecology
• Expedited Review: No
• Combination Product: No
• Applicant Address: Veru, Inc. 4400 Biscayne Blvd suite #888 miami, FL 33137
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P080002		Original Filing
S002	2016-03-01	Normal 180 Day Track
S001	2011-03-11	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
10861783000116	P080002	000
B0244LUWI1	P080002	000
40861783000100	P080002	000
00861783000102	P080002	000