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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namestimulator, neuromuscular, implanted
Generic Namemotor control neuroprosthesis
Regulation Number882.5860
PMA NumberP950035
Date Received10/31/1995
Decision Date08/15/1997
Product Code
GZC[ Registered Establishments with GZC ]
Docket Number 97M-0458
Notice Date 11/14/1997
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination Product No
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