Duns Number:144998551
Device Description: The Model 2200A-47E Anterior Lead is provided sterile for implantation. It is a flexible l The Model 2200A-47E Anterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/iridium tip and ring electrodes with an insulated lead body. Electrical current is delivered to the tip electrode which is implanted to be in contact with the anterior trunk of the vagus nerve to block nerve signals. The ring electrode is placed in contact with the stomach to measure lead impedance. Sutures are used to anchor and stabilize the lead placement. The lead is connected to the implanted Rechargeable Neuroregulator.
Catalog Number
2200A-47E
Brand Name
Model 2200A-47E Maestro Anterior Lead
Version/Model Number
2200A-47E
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 01, 2019
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
-
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
P130019
Product Code
PIM
Product Code Name
neuromodulator for obesity
Public Device Record Key
f88957e9-84eb-4ec6-9a7d-17cdd28522eb
Public Version Date
September 17, 2020
Public Version Number
5
DI Record Publish Date
April 17, 2015
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| 3 | A medical device with high risk that requires premarket approval | 20 |