DEVICE: VNS Therapy® Model 250 v8.1 Programming Software (X50) (05425025750184)
Device Identifier (DI) Information
VNS Therapy® Model 250 v8.1 Programming Software (X50)
250 v8.1 (X50)
In Commercial Distribution
LIVANOVA USA, INC.
250 v8.1 (X50)
In Commercial Distribution
LIVANOVA USA, INC.
Programming Software
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
44077 | Vagus nerve electrical stimulation system programmer |
A device intended to be used to change, noninvasively, one or more of the operating parameters (the programs) of an implanted stimulator used for vagus nerve stimulation (VNS). It is able to read stored parameters in the implanted device, providing historic and/or current information regarding device performance. The device is typically an electronic wand with a communication antenna that connects to the port of a personal computer (PC) with dedicated software. The PC will then drive the electronics of the wand to communicate with the implanted stimulation system.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MUZ | Stimulator, Autonomic Nerve, Implanted (Depression) |
LYJ | Stimulator, Autonomic Nerve, Implanted For Epilepsy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P970003 | 148 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -20 and 55 Degrees Celsius |
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6f5a5815-3c75-452d-b4fd-a95446c88635
July 06, 2018
3
September 17, 2014
July 06, 2018
3
September 17, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1 (866) 882-8804
ClinicalTechnicalServices@cyberonics.com
ClinicalTechnicalServices@cyberonics.com