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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 SYSTEM
Classification Namestimulator, autonomic nerve, implanted for epilepsy
Generic Namepulse generator
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS034
Date Received05/21/2001
Decision Date06/29/2001
Product Code
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 the model 101 in-line pulse generator (version 2. 0), model 302 in-line bipolar leads (version 1. 0), model 402 in-line tunneling tool (version 1. 0 and labeling changes.
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