LIVANOVA USA, INC.

Address:100 CYBERONICS BLVD.,HOUSTON,TX,77058,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Autonomic Nerve, Implanted For Epilepsy (LYJ) (10) Stimulator, Autonomic Nerve, Implanted (Depression) (MUZ) (9)

Premarket Exempt

No Yes

Clear

VNS Therapy® Demipulse® Model 103 Generator - 05425025750030 Catalog Number :

Device Description : Implantable Pulse Generator

Device Class : 3

Duns Number: 194568978

Premarket Exempt : No

Product Code : MUZ, LYJ

Prescription Use : Yes

Device Count : 1

VNS Therapy® Demipulse Duo® Model 104 Generator - 05425025750047 Catalog Number :

Device Description : Implantable Pulse Generator

Device Class : 3

Duns Number: 194568978

Premarket Exempt : No

Product Code : MUZ, LYJ

Prescription Use : Yes

Device Count : 1

VNS Therapy® AspireHC® Model 105 Generator - 05425025750054 Catalog Number :

Device Description : Implantable Pulse Generator

Device Class : 3

Duns Number: 194568978

Premarket Exempt : No

Product Code : MUZ, LYJ

Prescription Use : Yes

Device Count : 1

VNS Therapy® AspireSR® Model 106 Generator - 05425025750061 Catalog Number :

Device Description : Implantable Pulse Generator

Device Class : 3

Duns Number: 194568978

Premarket Exempt : No

Product Code : LYJ

Prescription Use : Yes

Device Count : 1

VNS Therapy® Model 302 Lead - 05425025750092 Catalog Number :

Device Description : Implantable Bipolar Lead

Device Class : 3

Duns Number: 194568978

Premarket Exempt : No

Product Code : MUZ, LYJ

Prescription Use : Yes

Device Count : 1

VNS Therapy® Model 302 Lead - 05425025750108 Catalog Number :

Device Description : Implantable Bipolar Lead

Device Class : 3

Duns Number: 194568978

Premarket Exempt : No

Product Code : MUZ, LYJ

Prescription Use : Yes

Device Count : 1

VNS Therapy® PerenniaDURA® Model 303 Lead - 05425025750115 Catalog Number :

Device Description : Implantable Lead

Device Class : 3

Duns Number: 194568978

Premarket Exempt : No

Product Code : MUZ, LYJ

Prescription Use : Yes

Device Count : 1

VNS Therapy® PerenniaDURA® Model 303 Lead - 05425025750122 Catalog Number :

Device Description : Implantable Lead

Device Class : 3

Duns Number: 194568978

Premarket Exempt : No

Product Code : MUZ, LYJ

Prescription Use : Yes

Device Count : 1

VNS Therapy® PerenniaFLEX® Model 304 Lead - 05425025750139 Catalog Number :

Device Description : Implantable Lead

Device Class : 3

Duns Number: 194568978

Premarket Exempt : No

Product Code : MUZ, LYJ

Prescription Use : Yes

Device Count : 1

VNS Therapy® PerenniaFLEX® Model 304 Lead - 05425025750153 Catalog Number :

Device Description : Implantable Lead

Device Class : 3

Duns Number: 194568978

Premarket Exempt : No

Product Code : MUZ, LYJ

Prescription Use : Yes

Device Count : 1

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