FDA-Device2019-11-13Class II
The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagu
LivaNova USA Inc
Hazard
Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VNS generator takes the lead impedance measurement during diagnostic testing. As a result, normal impedance ranges for the affected VNS generator have shifted relative to the existing thresholds of 600 - 5300 Ohms defined in labeling and as present in the programming software.
Sold states
US: PA, WV, KY, NY, MD, VA, DC, NC, GA, SC, NJ, DE, MA, OH, RI, CT, ME, NH, VT, IL, WI, IN, MO, MI, MN, SD, ND, NE,KS, IA, TX, OK, TN, MS, AL, FL, LA, ID, MT, WA, OR, UT, AK, AZ, AZ , CO, WY, NM, CA, HI, AR. Foreign (OUS): Austria, Switzerland, Germany, Denmark, Spain, Finland, United Kingdom, Italy, Netherlands, Norway, Portugal, Sweden
Affected count
9282
Manufactured in
100 Cyberonics Blvd, N/A, Houston, TX, United States
Products
The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0346-2020Don't want to check this manually?
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