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).

DeviceFC2 FEMALE CONDOM
Classification NameSingle-use Internal Condom
Generic NameSingle-use Internal Condom
ApplicantVeru, Inc.
Date Received2008-01-08
Decision Date2009-03-10
Notice Date2009-03-25
PMAP080002
SupplementS
Product CodeMBU
Docket Number09M-0159
Advisory CommitteeObstetrics/Gynecology
Expedited ReviewNo
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 NumberDateSupplement Type
P080002Original Filing
S002 2016-03-01 Normal 180 Day Track
S001 2011-03-11 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
10861783000116 P080002 000
B0244LUWI1 P080002 000
40861783000100 P080002 000
00861783000102 P080002 000

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