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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.
 
DevicePULSE AND PULSE DUO GENERATORS, DEMIPULSE AND DEMIPULSE DUO GENERATORS, ASPIREHC MODEL 105 GENERATOR
Classification Namestimulator, autonomic nerve, implanted (depression)
Generic Namestimulator, autonomic nerve, implanted (depression)
Applicant
Cyberonics, Inc.
100 cyberonics blvd.
houston, TX 77058-2017
PMA NumberP970003
Supplement NumberS159
Date Received03/11/2013
Decision Date04/03/2013
Product Code
MUZ[ Registered Establishments with MUZ ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Addition of storage/processing requirements for certain components.
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