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 revisions to the labeling that specify the maximum depth below the surface of the skin at which the implantable receiver-stimulator (irs) should not exceed when implanted and clarifying the instructions for connecting the external controller to the clinical programming station.
| Device | NEUROCONTROL FREEHAND SYSTEM |
| Classification Name | Stimulator, Neuromuscular, Implanted |
| Generic Name | Stimulator, Neuromuscular, Implanted |
| Applicant | BIOCONTROL TECHNOLOGY, INC. |
| Date Received | 2001-08-14 |
| Decision Date | 2001-09-13 |
| PMA | P950035 |
| Supplement | S010 |
| Product Code | GZC |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |