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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceNEUROCONTROL FREEHAND SYSTEM
Classification Namestimulator, neuromuscular, implanted
Generic Namestimulator, neuromuscular, implanted
Regulation Number882.5860
Applicant
BIOCONTROL TECHNOLOGY, INC.
1945 east 97th
cleveland, OH 44106-4720
PMA NumberP950035
Supplement NumberS008
Date Received07/11/2000
Decision Date11/14/2000
Product Code
GZC[ Registered Establishments with GZC ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
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.
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