| 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 | ITREL 3, ITREL 4, SYNERGY, SYNERGY VERSITREL, RESTORE, RESTOREPRIME, ADVANCEDRESTORE, ULTRA, ENS |
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| Classification Name | stimulator, spinal-cord, totally implanted for pain relief |
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| Applicant | MEDTRONIC INC. |
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| PMA Number | P840001 |
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| Supplement Number | S230 |
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| Date Received | 10/05/2012 |
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| Decision Date | 12/17/2012 |
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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 - 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 minor changes to model 8840 nvision programmer software for end of service and low/ empty reservoir alarms. |
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