| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | NEUROCONTROL FREEHAND SYSTEM(R) |
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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 | BIOCONTROL TECHNOLOGY, INC. |
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| PMA Number | P950035 |
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| Date Received | 10/31/1995 |
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| Decision Date | 08/15/1997 |
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| Product Code | |
| Docket Number | 97M-0458 |
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| Notice Date | 11/14/1997 |
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| Advisory Committee |
Ear Nose & Throat |
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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 freehand system(r). The system includes: implantable receiver-stimulator model 202-1, implantable epimysial electrode set model 203-1, surgical electrode positioning kit model 207-1, patient external system model 204-1, programming system model 209-1. The system is an upper extremity neuroprosthesis and is intended to improve a patient's ability to grasp, hold, and release objects. The system is indicated for use in patients who: are tetraplegic due to c5 or c6 spinal cord injury (asia classification); have adequate functional range of motion of the upper extremity; have intact lower motor neuron innervation of hte forearm and hand musculature; and are skeletally mature. |
| Supplements: |
S001 S002 S003 S004 S005 S006
S007 S008 S009 S010 |
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