Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S004 |
Date Received | 07/12/1993 |
Decision Date | 07/24/1995 |
Withdrawal Date
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09/01/2010 |
Product Code |
MBU |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
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 |
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