Identity
- Trade Name
- MARA Vapor System, MARA Vapor Probe Procedure Kit, MARA Vapor Generator and MARA Vapor Generator Accessory Kit FDA PMA
- Generic Name
- Device, thermal ablation, endometrial FDA PMA
Identifiers
- PMA Number
- P160047 FDA PMA
- FDA Product Code
- MNB FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Obstetrics/Gynecology FDA PMA
- FDA Decision
- APWD FDA PMA
The Mara Vapor System is a Device, Thermal Ablation, Endometrial, designed to ablate the endometrial lining of the uterus. It is intended for use in premenopausal women with menorrhagia caused by benign conditions where childbearing is complete. This procedure involves controlled thermal energy to reduce excessive uterine bleeding through targeted tissue ablation.
The system includes the Mara Vapor Probe Procedure Kit, Mara Vapor Generator, and Mara Vapor Generator Accessory Kit, all of which are supplied as a single-use, non-sterile device. It is regulated under FDA_PMA with approval number P160047, and its use is classified under Obstetrics/Gynecology advisory committees. The device operates in a clinical setting and requires proper training for application.
Frequently asked questions
What is the primary clinical use of the Mara Vapor System, and who is it intended for?
The Mara Vapor System is designed for **endometrial ablation**, a procedure to reduce excessive uterine bleeding (menorrhagia) in premenopausal women with benign conditions. It is specifically intended for women who have completed childbearing and experience heavy menstrual periods due to non-cancerous causes. The system delivers controlled thermal energy to the uterine lining to achieve tissue ablation.
Is the Mara Vapor System intended for single-use or reusable applications, and how is it supplied?
The Mara Vapor System is **supplied as a single-use device** and includes three components: the Mara Vapor Probe Procedure Kit, Mara Vapor Generator, and Mara Vapor Generator Accessory Kit. These components are **non-sterile** and must be prepared for use in a clinical setting before application.
How is the Mara Vapor System regulated, and what approval pathway was followed?
The Mara Vapor System is regulated under the **FDA’s Premarket Approval (PMA) pathway**, with approval number **P160047**. This classification applies to higher-risk devices, and the system was reviewed by the **Obstetrics/Gynecology (OB) Advisory Committee** before receiving clearance. The approval was granted in **June 2017** following a formal submission process.
What types of training or expertise are required to use the Mara Vapor System?
The Mara Vapor System is intended for use in a **clinical setting** and requires **proper training** for safe and effective application. While the data does not specify exact training requirements, its classification under **Obstetrics/Gynecology** and thermal ablation procedures implies that clinicians—such as gynecologists or reproductive endocrinologists—should be experienced in endometrial ablation techniques and familiar with thermal energy-based devices.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P160047 | Class III | Active |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA PMA P160047 24 fields · synced Oct 6, 2026