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Model 2200P-47E Maestro Posterior Lead

Reshape Lifesciences Inc. · Model 2200P-47E · UDI-DI 00857334004293

PIM Prescription

510(k) clearances

Adverse events

Recalls

Facilities

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.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.