|
Device | NEUROCONTROL FREEHAND SYSTEM |
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 | S010 |
Date Received | 08/14/2001 |
Decision Date | 09/13/2001 |
Product Code |
GZC |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |