Catalog Number

-

Brand Name

VNS Therapy® SenTiva Duo™ Model 1000-D Generator

Version/Model Number

1000-D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P970003

Product Code

LYJ

Product Code Name

Stimulator, Autonomic Nerve, Implanted For Epilepsy

Public Device Record Key

d71f4ba1-529e-40de-bf27-be38a5368a8a

Public Version Date

July 30, 2020

Public Version Number

1

DI Record Publish Date

July 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-