DEVICE: VNS Therapy® Demipulse® Model 103 Generator (05425025750030)

Device Identifier (DI) Information

VNS Therapy® Demipulse® Model 103 Generator
103
In Commercial Distribution

LIVANOVA USA, INC.
05425025750030
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
MUZ Stimulator, Autonomic Nerve, Implanted (Depression)
LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P970003 076
P970003 093
P970003 098
P970003 103
P970003 135
P970003 158
P970003 162
P970003 164
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Sterilization

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

[?]
Storage and Handling
Storage 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

8b518f49-3bc5-46f0-893c-38695fc6cecb
July 06, 2018
3
September 17, 2014
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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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