Stimulator, Autonomic Nerve, Implanted For Epilepsy
Basic Information
- Device Name
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Trade Name
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- PMA Number
- P970003
- Supplement Number
- S045
- Device Class
- FDA Class 3
- Product Code
- LYJ
- Generic Name
- STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 28, 2003
- Date Received
- October 24, 2002
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee 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."
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LYJ | Stimulator, Autonomic Nerve, Implanted For Epilepsy | FDA class 3 | Unknown |