|
Device | NEUROCONTROL FREEHAND SYSTEM(R) |
Generic Name | Stimulator, neuromuscular, implanted |
Regulation Number | 882.5860 |
Applicant | BIOCONTROL TECHNOLOGY, INC. 1945 EAST 97TH CLEVELAND, OH 44106-4720 |
PMA Number | P950035 |
Supplement Number | S001 |
Date Received | 02/10/1998 |
Decision Date | 03/20/1998 |
Product Code |
GZC |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |