|
Device | REALITY FEMALE CONDOM |
Generic Name | Single-use internal condom |
Regulation Number | 884.5340 |
Applicant | THE FEMALE HEALTH CO. 515 NORTH STATE ST. SUITE 2225 CHICAGO, IL 60654 |
PMA Number | P910064 |
Supplement Number | S013 |
Date Received | 02/28/1997 |
Decision Date | 03/07/1997 |
Withdrawal Date
|
09/01/2010 |
Product Code |
MBU |
Docket Number | N |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |