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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.
 
Trade NameNEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Classification Namestimulator, autonomic nerve, implanted for epilepsy
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS070
Date Received07/17/2006
Decision Date09/05/2006
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change from adding a strain relief grommet to the serial data cable of the model 201 programming wand during final assembly to molding an improved strain relief onto the serial data cable during its manufacture and changes to the tie-down used in the model 302 lead, the model 303 lead, and the model 502 accessory pack.
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