This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for a change in the supplier of the platinum-iridium (pt-ir) electrode discs used in the manufacture of the freehand epimysial electrodes and a change in the model numbering for the freehand system.
| Device | NEUROCONTROL FREEHAND SYSTEM(R) |
| Generic Name | Stimulator, Neuromuscular, Implanted |
| Applicant | BIOCONTROL TECHNOLOGY, INC. |
| Date Received | 1998-02-10 |
| Decision Date | 1998-03-20 |
| PMA | P950035 |
| Supplement | S001 |
| Product Code | GZC |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Real-time Process |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |