PMA P160047S008
- Device
- Mara Water Vapor Ablation System
- Applicant
- CooperSurgical, Inc.
- Product code
- MNB
- Decision date
- 2020-06-17
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for software changes to fix known anomalies identified in P160047/ S006 and to include device-specific user authentication.
Current openFDA PMA Record#
- Device
- Mara Water Vapor Ablation System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S008
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2020-06-17
- Decision code
- APPR
- Date received
- 2020-03-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software changes to fix known anomalies identified in P160047/ S006 and to include device-specific user authentication.