| 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 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM |
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| Classification Name | device, incontinence, mechanical/hydraulic |
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| Generic Name | urinary prosthesis |
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| Regulation Number | 876.5280 |
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| Applicant | AMERICAN MEDICAL SYSTEMS, INC. |
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| PMA Number | P000053 |
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| Supplement Number | S002 |
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| Date Received | 01/15/2004 |
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| Decision Date | 03/16/2004 |
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| Product Code | |
| Advisory Committee |
Gastroenterology/Urology |
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| Supplement Type | real-time process |
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| Supplement Reason | labeling change - minor |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for revision of the labeling to describe an alternate surgical approach (i. E. , transverse scrotal implantation). |
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