PMA P160047S030
- Device
- Mara Water Vapor Ablation System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S030
- Product code
- MNB
- Decision date
- 2023-06-30
- Classification
- Obstetrics/Gynecology
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for changes in the software test values (RF test time and Middle Balloon test pressure) for verification and validation tests.
Current openFDA PMA Record#
- Device
- Mara Water Vapor Ablation System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S030
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2023-06-30
- Decision code
- APPR
- Date received
- 2023-05-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes in the software test values (RF test time and Middle Balloon test pressure) for verification and validation tests.