- Device
- Mara Water Vapor Ablation System, Mara Water Vapor System, Mara Console
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S024
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2021-04-19
- Decision code
- OK30
- Date received
- 2021-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the supply chain for manufacturing of the Mara Console to add additional qualified suppliers for components used in its assembly.