PMA P910064S007

Device: REALITY FEMALE CONDOM
Applicant: The Female Health Co.
PMA number: P910064
Supplement: S007
Product code: MBU
Decision date: 1995-07-31
Generic name: Single-use internal condom
Approval order statement: APPROVAL FOR CHANGE TO THE PROFESSIONAL MONOGRAPH & PATIENT DEVICE LABELING TO INCLUDE INFORMATION ON, OR INSTRUCTIONS FOR, THE CONCOMITANT USE OF A SPERMICIDE CONTAINING NONOXYNOL-9 W/REALITY FEMALE CONDOM

Current openFDA PMA Record

Device: REALITY FEMALE CONDOM
Applicant: The Female Health Co.
PMA number: P910064
Supplement: S007
Product code: MBU
Generic name: Single-use internal condom
Decision date: 1995-07-31
Decision code: APPR
Date received: 1993-10-04
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGE TO THE PROFESSIONAL MONOGRAPH & PATIENT DEVICE LABELING TO INCLUDE INFORMATION ON, OR INSTRUCTIONS FOR, THE CONCOMITANT USE OF A SPERMICIDE CONTAINING NONOXYNOL-9 W/REALITY FEMALE CONDOM