PMA P160047S026
- Device
- Mara Water Vapor System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S026
- Product code
- MNB
- Decision date
- 2022-01-25
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Change to the outer diameter of the internal balloon component to ensure final component meets specification.
Current openFDA PMA Record#
- Device
- Mara Water Vapor System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S026
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2022-01-25
- Decision code
- OK30
- Date received
- 2022-01-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the outer diameter of the internal balloon component to ensure final component meets specification.