| 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 | VNS THERAPY PULSE GENERATORS |
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| Classification Name | stimulator, autonomic nerve, implanted for epilepsy |
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| Applicant | CYBERONICS, INC. |
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| PMA Number | P970003 |
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| Supplement Number | S081 |
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| Date Received | 04/30/2007 |
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| Decision Date | 05/14/2007 |
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| Product Code | |
| Advisory Committee |
Neurology |
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| Supplement Type | Special Supplement |
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| Supplement Reason | labeling change - other |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval to add additional precautionary information to the model 300 lead physician?s manual as an errata sheet and to revise the model 102, 102r, 302 and 303 vns therapy physician?s manual module entitled ?introduction to the vns therapy (system indications, contraindications, warnings, and precautions). ?. |
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