| 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(R) THERAPY FOR URINARY CONTROL |
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| Classification Name | stimulator, electrical, implantable, for incontinence |
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| Generic Name | patient programmer |
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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 | S012 |
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| Date Received | 02/20/2001 |
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| Decision Date | 08/06/2001 |
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| Product Code | |
| Advisory Committee |
Gastroenterology/Urology |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | change design/components/specifications - component |
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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 model 3031a patient programmer for use with the medtronic(r) interstim(r) therapy for urinary control, which is indicated for the treatment of urinary urge incontinence, urinary retention, and significant symptoms of urgency/frequency in patients who have failed or could not tolerate more conservative treatments. |
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