Mara Water Vapor System
FDA premarket approval P160047/S006 · decided 2020-01-16
Approval details
- PMA number
- P160047
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Mara Water Vapor System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- CooperSurgical, Inc.
- Date received
- 2019-09-05
- Decision date
- 2020-01-16
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Trumbull, CT
- 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 ch
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