PMA P910064S008

Device
Reality Female Condom
Applicant
THE FEMALE HEALTH CO.
PMA number
P910064
Supplement
S008
Decision date
1995-07-31

Current openFDA PMA Record

Device
REALITY FEMALE CONDOM
Applicant
The Female Health Co.
PMA number
P910064
Supplement
S008
Product code
MBU
Generic name
Single-use internal condom
Decision date
1995-07-31
Decision code
APPR
Date received
1993-12-27
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR AN EXTENSION OF PRODUCT SHELF LIFE:EXPIRATION DATING 36 MONTHS

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