| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | REALITY FEMALE CONDOM |
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| Classification Name | condom, female, single-use |
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| Regulation Number | 884.5330 |
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| Applicant | THE FEMALE HEALTH CO. |
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| PMA Number | P910064 |
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| Supplement Number | S013 |
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| Date Received | 02/28/1997 |
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| Decision Date | 03/07/1997 |
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| Product Code | |
| Docket Number | N |
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| Advisory Committee |
Obstetrics/Gynecology |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | labeling change - shelf-life |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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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. |
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