Identity
- Trade Name
- MAESTRO RECHARGEABLE SYSTEM FDA PMA
- Generic Name
- neuromodulator for obesity FDA PMA
Identifiers
- PMA Number
- P130019 FDA PMA
- FDA Product Code
- PIM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APWD FDA PMA
The Maestro Rechargeable System is a neuromodulator for obesity, classified as a device intended to aid weight reduction in patients aged 18 and older. It is designed to be implanted and electrically stimulates the vagus nerve to help manage appetite and promote weight loss in individuals with a body mass index (BMI) of 40 to 45 kg/m², or a BMI of 35 to 39.9 kg/m² with obesity-related comorbidities who have previously failed supervised weight management programs.
This device is supplied as a rechargeable, implantable system and is regulated under FDA Premarket Approval (PMA) with PMA number P130019. It is intended for use in clinical settings by trained healthcare professionals and requires proper sterilization and handling per manufacturer guidelines. The system is not MRI-safe and must be stored and maintained according to approved protocols to ensure functionality and patient safety.
Frequently asked questions
What is the primary purpose of the Maestro Rechargeable System and who is it intended for?
The Maestro Rechargeable System is a neuromodulator designed to aid weight reduction by electrically stimulating the vagus nerve. It is intended for patients aged 18 and older with a BMI of 40 to 45 kg/m², or a BMI of 35 to 39.9 kg/m² who have obesity-related comorbidities and have previously failed supervised weight management programs within the past five years.
How is the Maestro Rechargeable System powered and what does this mean for patients?
The Maestro Rechargeable System is designed as a rechargeable, implantable device, meaning patients will need to periodically recharge it externally to maintain functionality. This ensures continuous electrical stimulation of the vagus nerve for weight management without requiring frequent surgical interventions.
Is the Maestro Rechargeable System safe for use in MRI environments, and what storage guidelines should be followed?
The Maestro Rechargeable System is explicitly **not** MRI-safe, so patients must avoid MRI scans while the device is implanted. It must be stored and maintained according to manufacturer-provided protocols to preserve functionality and ensure patient safety, including proper handling and sterilization procedures.
What regulatory pathway does the Maestro Rechargeable System follow, and how does this affect its use?
The Maestro Rechargeable System follows the FDA Premarket Approval (PMA) pathway, with PMA number **P130019**, confirming it has undergone rigorous review for safety and effectiveness. This means it is intended for use only in clinical settings by trained healthcare professionals, adhering to strict medical guidelines and protocols.
Are there different sizes or models of the Maestro Rechargeable System, and how is it typically supplied?
The provided data does not specify multiple sizes or models of the Maestro Rechargeable System, but it is supplied as a single, rechargeable, implantable system. The device is intended for surgical implantation by trained professionals and comes with manufacturer guidelines for proper handling, sterilization, and maintenance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Keine Maestro-Funktion mehr für Girokarten - Verbraucherzentrale.de, Maestro Rechargeable System PMA P130019 - FDA.report, Maestro Rechargeable System PMA P130019S019 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P130019 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ReShape Lifesciences Inc.
- FDA Applicant
- Reshape Lifesciences, Inc.
Sources (1)
- FDA PMA P130019 24 fields · synced Sep 18, 2026