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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 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.
 
DeviceNEUROCONTROL FREEHAND SYSTEM
Generic NameStimulator, neuromuscular, implanted
Regulation Number882.5860
ApplicantBiocontrol Technology, Inc.
1945 E. 97th
Cleveland, OH 44106
PMA NumberP950035
Supplement NumberS008
Date Received07/11/2000
Decision Date11/14/2000
Product Code GZC 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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