- Device
- Mara Water Vapor System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S006
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2020-01-16
- Decision code
- APPR
- Date received
- 2019-09-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.