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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 NamePULSE AND PULSE DUO GENERATORS, DEMIPULSE AND DEMIPULSE DUO GENERATORS, ASPIREHC MODEL 105 GENERATOR
Classification Namestimulator, autonomic nerve, implanted for epilepsy
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS159
Date Received03/11/2013
Decision Date04/03/2013
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Addition of storage/processing requirements for certain components.
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