Model 2200P-47E Maestro Posterior Lead - The Model 2200P-47E Posterior Lead is provided - Reshape Lifesciences Inc.

Duns Number:144998551

Device Description: The Model 2200P-47E Posterior Lead is provided sterile for implantation. It is a flexible The Model 2200P-47E Posterior 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 posterior 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. The Posterior Lead contains a white stripe along the lead body, a white suture tab, and a white coating on its' conductor cables to distinguish it from the Anterior Lead.

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More Product Details

Catalog Number

2200P-47E

Brand Name

Model 2200P-47E Maestro Posterior Lead

Version/Model Number

2200P-47E

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 2019

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

PIM

Product Code Name

neuromodulator for obesity

Device Record Status

Public Device Record Key

3f438421-ed11-4e4f-9a40-e369e40e555e

Public Version Date

September 17, 2020

Public Version Number

5

DI Record Publish Date

April 17, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESHAPE LIFESCIENCES INC." Characteristics
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