PMA P910064S013
- Device
- Reality Female Condom
- Applicant
- THE FEMALE HEALTH CO.
- PMA number
- P910064
- Supplement
- S013
- Decision date
- 1997-03-07
Current openFDA PMA Record
- Device
- REALITY FEMALE CONDOM
- Applicant
- The Female Health Co.
- PMA number
- P910064
- Supplement
- S013
- Product code
- MBU
- Generic name
- Single-use internal condom
- Decision date
- 1997-03-07
- Decision code
- APPR
- Date received
- 1997-02-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR 1)A MODIFICATION OF THE SHELF LIFE PROTOCOL TO REVISE THE FILM STRENGTH SPECIFICATION FROM 35 MPA TO 25.8 MPA; 2) A MODIFICATION ON THE SHELF LIFE PROTOCOL TO ASSESS THE FINAL RESULTS OF EACH LOT ON AN INDIVIDUAL BASIS, INSTEAD OF AS AN AVERAGE OF A SERIES; AND 3) AN EXTENSION OF THE PRODUCT SHELF LIFE FROM 36 MONTHS TO 60 MONTHS FOR PRODUCT PRODUCT MANUFACTURED AT BOTH THE WISCONSIN PHARMACAL AND THE CHARTEX MANUFACTURING PLANTS.