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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Generic NameStimulator, autonomic nerve, implanted for epilepsy
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS033
Date Received05/07/2001
Decision Date06/07/2001
Product Code LYJ 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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