PMA P910064S004

Device: REALITY FEMALE CONDOM
Applicant: The Female Health Co.
PMA number: P910064
Supplement: S004
Product code: MBU
Decision date: 1995-07-24
Generic name: Single-use internal condom
Approval order statement: PROVIDED ADD'L DATA ON THE IN VITRO BARRIER PROPERTIES OF THE DEVICE WITH RESPECT TO SEXUALLY TRANSMITTED DISEASES. THESE DATA WERE PROVIDED IN SATISFACTION OF THE CONDITIONS OF APPROVAL CONTAINED IN FDA'S MAY 7, 1993 LETTER

Current openFDA PMA Record

Device: REALITY FEMALE CONDOM
Applicant: The Female Health Co.
PMA number: P910064
Supplement: S004
Product code: MBU
Generic name: Single-use internal condom
Decision date: 1995-07-24
Decision code: APPR
Date received: 1993-07-12
Supplement type: Normal 180 Day Track
Supplement reason: Other
Approval order statement: PROVIDED ADD'L DATA ON THE IN VITRO BARRIER PROPERTIES OF THE DEVICE WITH RESPECT TO SEXUALLY TRANSMITTED DISEASES. THESE DATA WERE PROVIDED IN SATISFACTION OF THE CONDITIONS OF APPROVAL CONTAINED IN FDA'S MAY 7, 1993 LETTER