DEVICE: VNS Therapy® AspireSR® Model 106 Generator (05425025750061)

Device Identifier (DI) Information

VNS Therapy® AspireSR® Model 106 Generator
106
In Commercial Distribution

LIVANOVA USA, INC.
05425025750061
GS1

1
194568978 *Terms of Use
Implantable Pulse Generator
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Device Characteristics

MR Conditional
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Antiseizure/psychiatric-therapy vagus nerve electrical stimulation system An assembly of battery-powered sterile devices intended to apply periodic electrical stimuli to the vagus nerve to help control seizures and/or to help treat psychiatric disorder symptoms (e.g., depression). The vagus nerve stimulation (VNS) is provided through a pulse generator, typically implanted in the anterior chest wall, and leads that run subcutaneously to where their electrodes are implanted around the left vagus nerve. The system may be programmed externally following implantation.
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FDA Product Code

[?]
Product Code Product Code Name
LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P970003 173
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between -20 and 55 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

d5a7f0b0-15c7-45f1-892f-0e7e667c15fc
July 06, 2018
3
June 02, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
1 (866) 882-8804
ClinicalTechnicalServices@cyberonics.com
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