Device, Thermal Ablation, Endometrial
Basic Information
- Device Name
- Device, Thermal Ablation, Endometrial
- Trade Name
- Mara Water Vapor System
- PMA Number
- P160047
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- MNB
- Generic Name
- Device, thermal ablation, endometrial
- Medical Specialty
- Unknown
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 16, 2020
- Date Received
- September 5, 2019
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for a change in device design to change the location and method of vapor generation. These include changes in the fluid source for vapor generation from water to saline, modification of the vapor probe to generate vapor within the handle, modification of the console to control saline delivery without directly contacting the saline, changes in the feedback controls associated with the change in vapor generation, and changes in packaging, sterilization, and reprocessing associated with changes in the patient contact status of the console. In addition, this supplement includes changes in the location in which AEGEA Medical Inc. will manufacture the vapor probe to Menlo Park, CA, establishment of contract manufacturing of the console by Nextern, Inc. in White Bear Leak, MN, and change in the supplier of sterilization of the vapor probe to Sterigenics in Los Angeles, California.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MNB | Device, Thermal Ablation, Endometrial | FDA class 3 | Unknown |