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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 (NCP) SYSTEM
Classification Namestimulator, autonomic nerve, implanted for epilepsy
Generic Namepulse generator
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS033
Date Received05/07/2001
Decision Date06/07/2001
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes. The changes are intended to: 1) add a warning that recommends that physicians use care when treating patients with pre-existing obstructive sleep apnea (osa), and 2) add and strengthen precautions regarding: a) electrosurgery, b) therapeutic ultrasound, c) exposure to environments that are protected by a warning notice preventing entry by patients with an implanted pacemaker, and d) application of other therapies involving electric current, such as tens devices.
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