PMA P160047S036
- Device
- MARA Water Vapor Ablation System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S036
- Product code
- MNB
- Decision date
- 2024-05-10
- Classification
- Obstetrics/Gynecology
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- modification of parameters of Branson Ultrasonic Welder Unit used to manufacture mesh filters used in MARA Water Vapor System Probe
Current openFDA PMA Record#
- Device
- MARA Water Vapor Ablation System
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S036
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2024-05-10
- Decision code
- OK30
- Date received
- 2024-04-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- modification of parameters of Branson Ultrasonic Welder Unit used to manufacture mesh filters used in MARA Water Vapor System Probe