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 1) changing the manufacturing site for the freehand implantable receiver-stimulator to lewicki microelectronic, gmbh; 2) addition of a radiographic identification label to the implantable receiver-stimulator; and 3) implementing several design modifications involving the encapsulating material and circuitry of the freehand implantable receiver-stimulator.
| Device | NEUROCONTROL FREEHAND SYSTEM |
| Classification Name | Stimulator, Neuromuscular, Implanted |
| Generic Name | Stimulator, Neuromuscular, Implanted |
| Applicant | BIOCONTROL TECHNOLOGY, INC. |
| Date Received | 2000-07-11 |
| Decision Date | 2000-11-14 |
| PMA | P950035 |
| Supplement | S008 |
| 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 |