NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
FDA premarket approval P970003/S045 · decided 2003-02-28
Approval details
- PMA number
- P970003
- Supplement
- S045
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2002-10-24
- Decision date
- 2003-02-28
- Days to decision
- 127 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- 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
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| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
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