This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
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.
| Device | NEUROCONTROL FREEHAND SYSTEM(R) |
| Classification Name | Stimulator, Neuromuscular, Implanted |
| Generic Name | Stimulator, Neuromuscular, Implanted |
| Applicant | BIOCONTROL TECHNOLOGY, INC. |
| Date Received | 1995-10-31 |
| Decision Date | 1997-08-15 |
| Notice Date | 1997-11-14 |
| PMA | P950035 |
| Supplement | S |
| Product Code | GZC |
| Docket Number | 97M-0458 |
| Advisory Committee | Physical Medicine |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOCONTROL TECHNOLOGY, INC. 1945 East 97th cleveland, OH 44106-4720 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950035 | Original Filing | |
| S010 | 2001-08-14 | Special (immediate Track) |
| S009 | 2000-12-22 | Normal 180 Day Track |
| S008 | 2000-07-11 | Normal 180 Day Track |
| S007 | 2000-03-14 | Real-time Process |
| S006 | 2000-02-29 | Normal 180 Day Track |
| S005 | 1999-11-24 | Real-time Process |
| S004 | 1999-04-07 | Normal 180 Day Track |
| S003 | 1998-12-02 | Normal 180 Day Track |
| S002 | 1998-06-29 | Special (immediate Track) |
| S001 | 1998-02-10 | Real-time Process |