| 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 | NEUROCONTROL FREEHAND SYSTEM |
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| Classification Name | stimulator, neuromuscular, implanted |
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| Generic Name | motor control neuroprosthesis |
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| Regulation Number | 882.5860 |
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| Applicant | NEUROCONTROL CORP. |
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| PMA Number | P950035 |
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| Supplement Number | S003 |
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| Date Received | 12/02/1998 |
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| Decision Date | 01/19/1999 |
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| Product Code | |
| Advisory Committee |
Ear Nose & Throat |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | location change: manufacturer |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for a new manufacturing site located at neurocontrol corporation, 8333 rockside road, valley view, oh. |
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