| 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 | MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL, LEAD MODELS 3080, 3886, 3889, 3092, 3093, 3966, AND 3095 |
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| Classification Name | stimulator, electrical, implantable, for incontinence |
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| Generic Name | implantable system for sacral nerve stimulation |
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| Regulation Number | 876.5270 |
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| Applicant | MEDTRONIC VASCULAR |
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| PMA Number | P970004 |
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| Supplement Number | S028 |
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| Date Received | 05/12/2004 |
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| Decision Date | 05/27/2004 |
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| Product Code | |
| Advisory Committee |
Gastroenterology/Urology |
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| Supplement Type | 30-day notice |
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| Supplement Reason | process change: manufacturing |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Change in the supplier of raw materials used to manufacture the products. |
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