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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.
Classification Namestimulator, autonomic nerve, implanted for epilepsy
PMA NumberP970003
Supplement NumberS046
Date Received11/29/2002
Decision Date09/30/2003
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternative sterilization process (hydrogen peroxide gas plasma using the sterrad 200 gmp sterilizer) for the model 401 tunneler and approval of a protocol for b1 incubation reduction and shelf life study, as well as a new sterilization facility (cyberonics, inc. , houston, texas).