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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 II SYSTEM
Generic NameStimulator, neuromuscular, implanted
Regulation Number882.5860
ApplicantBiocontrol Technology, Inc.
1945 E. 97th
Cleveland, OH 44106
PMA NumberP950035
Supplement NumberS009
Date Received12/22/2000
Decision Date01/18/2002
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 THE UNIVERSAL EXTERNAL CONTROLLER (UEC), REVISED FREEHAND CLINICIAN PROGRAMMING INTERFACE SOFTWARE, VERSION 5.0, WHICH ARE USED TO OPERATE AND PROGRAM THE FREEHAND IMPLANTABLE-RECEIVER STIMULATOR, AND SUBSEQUENT CHANGES TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FREEHAND II SYSTEM.
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