Devices

Device Recall VNS Therapy AspireHC Pulse Generator

Model / Serial
Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.
Product Classification
Neurological Devices
Device Class
3
Implanted device?
Yes
Distribution
Distributed to PA.
Product Description
Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. || Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Manufacturer
Cyberonics, Inc
1 Event
- Recall of Device Recall VNS Therapy AspireHC Pulse 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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