Model 2200P-47E Maestro Posterior Lead

Basic Information

• Brand Name: Model 2200P-47E Maestro Posterior Lead
• Primary DI: 00857334004293
• Version / Model: 2200P-47E
• Catalog Number: 2200P-47E
• Company Name: Reshape Lifesciences Inc.
• Labeler DUNS: 144998551
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-04-17
• Public Version: 6
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: 3f438421-ed11-4e4f-9a40-e369e40e555e
• Distribution End Date: 2019-06-01

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PIM	neuromodulator for obesity	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
44041	Vagus nerve electrical stimulation system lead	An implantable wire, insulated with non-conductive material except at its electrode(s), intended to be used to make an electrical connection between a pulse generator and the vagus nerve for vagus nerve stimulation (VNS).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857334004293	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P130019	000

Device Sizes

Type	Value	Unit	Text
Length	47	Centimeter

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 150 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius