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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 NameVNS THERAPY SYSTEM
Classification Namestimulator, autonomic nerve, implanted for epilepsy
Generic Namepulse generator
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS040
Date Received04/19/2002
Decision Date06/20/2002
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 modifications to the existing model 101 (version 2) in-line ncp pulse generator and model 302 (version 1) in-line ncp bipolar lead, resulting in the new vns therapy pulse, model 102 generator and the vns therapy lead, model 302 (version 1. 1). The device, as modified, will be marketed under the trade name vns therapy system.
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