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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 NumberS045
Date Received10/24/2002
Decision Date02/28/2003
Product Code LYJ 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE FOLLOWING LABELING CHANGE TO THE INDIVIDUALIZATION OF TREATMENT SECTION OF THE MODEL 100/101 AND 102 PHYSICIAN'S MANUALS "PRECLINICAL STUDY, TERATOGENIC EFFECTS; THERE ARE NO ADEQUATE AND WELL-CONTROLLED STUDIES OF VNS IN PREGNANT WOMEN. REPRODUCTION STUDIES HAVE BEEN PERFORMED USING FEMALE RABBITS STIMULATED WITH THE COMMERCIALLY AVAILABLE VNS THERAPY SYSTEM AT STIMULATION DOSE SETTINGS SIMILAR TO THOSE USED FOR HUMANS. THESE ANIMAL STUDIES HAVE REVEALED NO EVIDENCE OF IMPAIRED FERTILITY OR HARM TO THE FETUS DUE TO VNS THERAPY. BECAUSE ANIMAL REPRODUCTION STUDIES ARE NOT ALWAYS PREDICTIVE OF HUMAN RESPONSE AND ANIMAL STUDIES CANNOT ADDRESS DEVELOPMENTAL ABNORMALITIES, VNS SHOULD BE USED DURING PREGNANCY ONLY IF CLEARLY NEEDED. ALTHOUGH THE OPERATING RANGES OF THE VNS THERAPY SYSTEM AND FETAL MONITORS ARE DISSIMILAR AND NO INTERACTION WOULD BE EXPECTED, TESTING HAS NOT BEEN PERFORMED. THEREFORE, THE POTENTIAL MAY EXIST FOR INTERACTION BETWEEN THE VNS THERAPY SYSTEM AND FETAL MONITORING SYSTEMS."
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