Duns Number:194568978
Device Description: Implantable Pulse Generator
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
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 44 |
2 | A medical device with a moderate to high risk that requires special controls. | 479 |
3 | A medical device with high risk that requires premarket approval | 30 |