Devices

Device Recall VNS Therapy AspireSR Generator

Model / Serial
All VNS Therapy AspireSR (Model 106) Generators; Device Identifier - (01)05425025750061
Product Classification
Neurological Devices
Device Class
3
Implanted device?
Yes
Distribution
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.
Product Description
VNS Therapy AspireSR Generator Model 106. || Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Manufacturer
Cyberonics, Inc
1 Event
- Recall of Device Recall VNS Therapy AspireSR Generator

Manufacturer

Cyberonics, Inc

Manufacturer Address
Cyberonics, Inc, 100 Cyberonics Blvd, Houston TX 77058-2069
Manufacturer Parent Company (2017)
LivaNova PLC
Source
USFDA

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