PMA P160047S039

Device: Mara Water Vapor Ablation System
Applicant: CooperSurgical, Inc.
PMA number: P160047
Supplement: S039
Product code: MNB
Decision date: 2025-01-07
Classification: Obstetrics/Gynecology
Generic name: Device, thermal ablation, endometrial
Approval order statement: manufacturing updates to include a sensor plate tapping fixture to the sensor plate assembly process and update the calibration requirements for the outflow and inflow tube cutting fixtures

Current openFDA PMA Record#

Device: Mara Water Vapor Ablation System
Applicant: CooperSurgical, Inc.
PMA number: P160047
Supplement: S039
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2025-01-07
Decision code: OK30
Date received: 2024-12-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: manufacturing updates to include a sensor plate tapping fixture to the sensor plate assembly process and update the calibration requirements for the outflow and inflow tube cutting fixtures