VNS Therapy System

Model Catalog: 105 (Lot serial: >10 NUMBERS CONTACT MFR)

VNS THERAPY MODEL 105 ASPIREHC GENERATOR

Model Catalog: 250 (Lot serial: VERSIONS 6.1 7.0 7.1.3)

SEE 33-01

Model Catalog: 250 V7.1.4 (Lot serial: > 10 devices contact); Model Catalog: 250 V7.1.4 (Lot serial: manufacturer)

VNS THERAPY SYSTEM-PROGRAMMING SOFTWARE

All lots.

Neurological Devices

3

Yes

Worldwide Distribution - USA, Belgium, Germany, Norway, Spain, Sweden, the Netherlands, and United Kingdom.

Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable, multiprogrammable, vagus nerve stimulator.

For Software v6.1: 10-005-9400 and 10-006-0900; For Software v6.1.7: 10-0007-2400 and 10-0007-2500; For Software v7.0: 10-0007-4100 and 10-0007-2500; For Software v7.1.3: 10-0007-8400 and 10-0007-8500;

Neurological Devices

3

Yes

Worldwide Distribution ---- USA and countries of Argentina, Australia, Austria, Belgium, Canada, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, S. Korea, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.

Cyberonics VNS Therapy System, Model 250-''HAND HELD'' programming software v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX.