PMA P080002S002

Device
FC2 FEMALE CONDOM
Applicant
Clear Future, Inc.
PMA number
P080002
Supplement
S002
Product code
MBU
Decision date
2017-06-23
Classification
Single-use Internal Condom
Generic name
Single-use internal condom
Approval order statement
Approval for your proposed change in the formulation of the FC2 Female Condom.

Current openFDA PMA Record#

Device
FC2 FEMALE CONDOM
Applicant
Clear Future, Inc.
PMA number
P080002
Supplement
S002
Product code
MBU
Generic name
Single-use internal condom
Decision date
2017-06-23
Decision code
APPR
Date received
2016-03-01
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for your proposed change in the formulation of the FC2 Female Condom.