AspireSR Generator

Serial numbers 36602, 37019, 39097, 40311, 40465

Neurological Devices

3

Yes

US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.

Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106

All VNS Therapy AspireSR (Model 106) Generators; Device Identifier - (01)05425025750061

Neurological Devices

3

Yes

Worldwide Distribution -- United States, Austria, Belgium, Croatia, Czech Republic, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Cyprus, Israel, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, and United Arab Emirates.

VNS Therapy AspireSR Generator Model 106. || Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

Serial Number Expiration Date: 34898 6/16/2017 34916 6/16/2017 35981 4/16/2017 36098 4/27/2017 36101 4/16/2017 36103 4/16/2017 36309 3/31/2017 36310 3/31/2017 36312 3/31/2017 36395 3/31/2017 36397 3/31/2017 36399 3/31/2017 36406 5/20/2017 36411 5/20/2017 36415 5/20/2017 36416 5/20/2017 36418 5/20/2017 36427 5/20/2017 36428 5/20/2017 36444 3/31/2017 36445 3/31/2017 36461 5/20/2017 36465 5/20/2017 36466 5/20/2017 36467 5/20/2017 36468 5/20/2017 36475 5/20/2017 36491 5/20/2017 36498 5/20/2017 36501 5/26/2017 36502 5/26/2017 36504 5/26/2017 36508 5/26/2017 36512 5/26/2017 36513 5/26/2017 36536 3/31/2017 36538 3/31/2017 36540 3/31/2017 36541 5/20/2017 36542 5/26/2017 36543 5/26/2017 36544 5/26/2017 36545 3/31/2017 36547 3/31/2017 36548 3/31/2017 36549 3/31/2017 36553 3/31/2017 36557 3/31/2017 36559 5/26/2017 36560 3/31/2017 36561 3/31/2017 36562 3/31/2017 36566 3/31/2017 36569 5/26/2017 36570 3/31/2017 36571 3/31/2017 36572 3/31/2017 36573 3/31/2017 36579 3/31/2017 36581 3/31/2017 36583 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Neurological Devices

3

Yes

Worldwide Distribution - US Nationwide and Puerto Rico and the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Puerto Rico. Distribution internationally to Argentina, Austria, Belgium, Canada, Croatia, Czech Republic, Finland, Germany, Ireland, Israel, Italy, Japan, Lebanon, Netherlands, Norway, Poland, Qatar, Saudi Arabia, United Arab Emirates, and United Kingdom.

VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. || Product Usage: || United States Indications for Use: Epilepsy (PMA 970003): 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 that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated 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. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode

Model Number: 106

Active implantable medical devices

Cyberonics: AspireSR Generator Model 106