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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 NumberS010
Date Received08/14/2001
Decision Date09/13/2001
Product Code GZC 
Advisory Committee Ear Nose & Throat
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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