FC2 FEMALE CONDOM

Single-use Internal Condom

FDA Premarket Approval P080002 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for your proposed change in the formulation of the fc2 female condom.

• Device: FC2 FEMALE CONDOM
• Classification Name: Single-use Internal Condom
• Generic Name: Single-use Internal Condom
• Applicant: Veru, Inc.
• Date Received: 2016-03-01
• Decision Date: 2017-06-23
• PMA: P080002
• Supplement: S002
• Product Code: MBU
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: Veru, Inc. 4400 Biscayne Blvd suite #888 miami, FL 33137

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