PMA P160047S010
- Device
- Mara Water Vapor Ablation System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S010
- Product code
- MNB
- Decision date
- 2020-05-06
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Changes to improve a manufacturing process of the Interface PCB and modification of inspection steps of the Internal Balloon.
Current openFDA PMA Record#
- Device
- Mara Water Vapor Ablation System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S010
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2020-05-06
- Decision code
- OK30
- Date received
- 2020-04-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to improve a manufacturing process of the Interface PCB and modification of inspection steps of the Internal Balloon.