PMA P160047S038
- Device
- MARA Water Vapor Ablation System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S038
- Product code
- MNB
- Decision date
- 2024-07-09
- Classification
- Obstetrics/Gynecology
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for an additional incoming inspection step of label readability on the FISO Pressure Sensor tray.
Current openFDA PMA Record#
- Device
- MARA Water Vapor Ablation System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S038
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2024-07-09
- Decision code
- APPR
- Date received
- 2024-06-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional incoming inspection step of label readability on the FISO Pressure Sensor tray.