PMA P160047S011
- Device
- Mara Water Vapor Ablation System, Mara Water vapor Probe, Mara Console
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S011
- Product code
- MNB
- Decision date
- 2020-07-01
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Addition of the NRTL label (Nationally Recognized Test Lab label) to the back of the Mara Console.
Current openFDA PMA Record#
- Device
- Mara Water Vapor Ablation System, Mara Water vapor Probe, Mara Console
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S011
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2020-07-01
- Decision code
- OK30
- Date received
- 2020-06-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of the NRTL label (Nationally Recognized Test Lab label) to the back of the Mara Console.