Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, ID, IL, KS, OH, AR, MA, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OR, PA, TN, TX, UT, WA, WI and WV. Products were also distributed to WASHINGTON DC and Puerto Rico and the countries of: Austria, Belgium, Finland, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, and United Kingdom.
Description du dispositif
VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc. Houston, Texas, Model 103 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. || Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, ID, IL, KS, OH, AR, MA, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OR, PA, TN, TX, UT, WA, WI and WV. Products were also distributed to WASHINGTON DC and Puerto Rico and the countries of: Austria, Belgium, Finland, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, and United Kingdom.
Description du dispositif
Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. || Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
Worldwide: USA, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Poland, Portugal, Puerto Rico (US Territory), Russia, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Description du dispositif
Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version 4.6, 6.1, 7.0 and 7.1. The Model 250 Handheld software is provided on flashcards packaged in software envelopes or pre-installed on handheld computers.