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 | S006 |
Date Received | 08/30/1993 |
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 | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE FOCUS GROUP STUDY PROTOCOL TO ASSESS PATIENT COMPREHENSION OF PRODUCT LABELING |
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