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 the universal external controller (uec), revised freehand clinician programming interface software, version 5. 0, which are used to operate and program the freehand implantable-receiver stimulator, and subsequent changes to the labeling. The device, as modified, will be marketed under the trade name freehand ii system.
| Device | NEUROCONTROL FREEHAND II SYSTEM |
| Classification Name | Stimulator, Neuromuscular, Implanted |
| Generic Name | Stimulator, Neuromuscular, Implanted |
| Applicant | BIOCONTROL TECHNOLOGY, INC. |
| Date Received | 2000-12-22 |
| Decision Date | 2002-01-18 |
| PMA | P950035 |
| Supplement | S009 |
| Product Code | GZC |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |