| 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 | ESSURE SYSTEM |
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| Classification Name | insert, tubal occlusion |
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| Generic Name | device, occlusion, tubal, contraceptive |
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| Regulation Number | 884.5380 |
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| Applicant | CONCEPTUS, INC. |
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| PMA Number | P020014 |
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| Supplement Number | S005 |
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| Date Received | 11/10/2003 |
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| Decision Date | 06/10/2004 |
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| Product Code | |
| Advisory Committee |
Obstetrics/Gynecology |
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| Supplement Type | normal 180 day track no user fee |
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| Supplement Reason | labeling change - performance characteristics |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for the device labeling to include 3-year effectiveness results and other labeling changes. |
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