PMA P160047S035

Device: MARA Water Vapor Ablation System
Applicant: CooperSurgical, Inc.
PMA number: P160047
Supplement: S035
Product code: MNB
Decision date: 2024-07-11
Classification: Obstetrics/Gynecology
Generic name: Device, thermal ablation, endometrial
Approval order statement: Approval for the changes in the manufacturing process for the MARA water vapor probe to include the addition of silicone lubricant on the inside diameter of the tip cover.

Current openFDA PMA Record#

Device: MARA Water Vapor Ablation System
Applicant: CooperSurgical, Inc.
PMA number: P160047
Supplement: S035
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2024-07-11
Decision code: APPR
Date received: 2024-01-23
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the changes in the manufacturing process for the MARA water vapor probe to include the addition of silicone lubricant on the inside diameter of the tip cover.