| 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 | EON NEUROSTIMULATION (IPG), ANS EON C NEUROSTIMULATION (IPG), AND EON MINI NEUROSTIMULATION(IPG) |
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| Classification Name | stimulator, spinal-cord, totally implanted for pain relief |
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| Generic Name | implantable pulse generator system |
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| Applicant | ADVANCED NEUROMODULATION SYSTEM,INC |
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| PMA Number | P010032 |
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| Supplement Number | S029 |
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| Date Received | 04/02/2009 |
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| Decision Date | 06/01/2009 |
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| Product Code | |
| Advisory Committee |
Neurology |
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| Supplement Type | real-time process |
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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 penta lead kits (models 3227, 3228, 3229, 3230, 3231, 3232, 3233, and 3234). |
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