PMA P160047S034
- Device
- Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S034
- Product code
- MNB
- Decision date
- 2023-12-08
- Classification
- Obstetrics/Gynecology
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for a manufacturing site change
Current openFDA PMA Record#
- Device
- Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode
- Applicant
- CooperSurgical, Inc.
- PMA number
- P160047
- Supplement
- S034
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2023-12-08
- Decision code
- APPR
- Date received
- 2023-11-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site change