| 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 | INTERSTIM SYSTEM |
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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 | S019 |
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| Date Received | 11/15/2001 |
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| Decision Date | 12/14/2001 |
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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: packaging |
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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 sterile packaging operation from a class 10,000 controlled environment area (cea) to a class 100,000 cea. |
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