| 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 | GENESIS, GENESISXP/DUAL XP, GENESISRC, GENESIS DUAL 4-CHANNEL, EON, EONC, AND EONMINI NEUROSTIMULATION (IPG) SYSTEMS |
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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 SYSTEMS (ANS) |
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| PMA Number | P010032 |
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| Supplement Number | S031 |
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| Date Received | 07/01/2009 |
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| Decision Date | 07/31/2009 |
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| Product Code | |
| Advisory Committee |
Neurology |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | change design/components/specifications - software |
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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 rapid programmer software version 3. 3. 0. |
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