Model 2200P-47E Maestro Posterior Lead 2200P-47E

GUDID 00857334004293

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.

ENTEROMEDICS INC.

Vagus nerve electrical stimulation system lead
Primary Device ID00857334004293
NIH Device Record Key3f438421-ed11-4e4f-9a40-e369e40e555e
Commercial Distribution StatusIn Commercial Distribution
Brand NameModel 2200P-47E Maestro Posterior Lead
Version Model Number2200P-47E
Catalog Number2200P-47E
Company DUNS144998551
Company NameENTEROMEDICS INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com
Phone+1(651)789-2681
Emaillpritchard@enteromedics.com

Device Dimensions

Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter
Length47 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 150 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100857334004293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PIMneuromodulator for obesity

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


[00857334004293]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-04-17

Devices Manufactured by ENTEROMEDICS INC.

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00857334004194 - Model 1600 Maestro Programmer Cable2018-07-06 The Model 1600 Programmer Cable is a non-sterile external component that is used to provide connectivity between the Model 2502
00857334004217 - Model 1660 Maestro Patient Transmit Coil Belt2018-07-06 The Model 1660 Patient Transmit Coil Belt is a non-sterile, optional external accessory that may be used to assist in holding th
00857334004248 - Model 1680 Torque Wrench2018-07-06 The Model 1680 Torque Wrench is a sterile standard surgical wrench provided for use during the implant procedure to tighten the
00857334004262 - Model 2002 Maestro Rechargeable Neuroregulator2018-07-06 The Model 2002 Rechargeable Neuroregulator (RNR) is provided sterile for implantation and has a hermetic case enclosure with an
00857334004279 - Model 2004 Maestro Implant Kit2018-07-06 The Model 2004 Implant Kit consists of a Model 2002 Rechargeable Neuroregulator (including Model 1680 Torque Wrench), a Model 22
00857334004286 - Model 2200A-47E Maestro Anterior Lead2018-07-06 The Model 2200A-47E Anterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/iri
00857334004293 - Model 2200P-47E Maestro Posterior Lead2018-07-06The 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.
00857334004293 - Model 2200P-47E Maestro Posterior Lead2018-07-06 The Model 2200P-47E Posterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/ir

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