PMA P160047S028

Device: Mara Water Vapor Ablation System
Applicant: CooperSurgical, Inc.
PMA number: P160047
Supplement: S028
Product code: MNB
Decision date: 2023-01-19
Generic name: Device, thermal ablation, endometrial
Approval order statement: Change to the manufacturer and manufacturing of the Sleeve Cartridge Sub-Assembly, Outflow Tube Sub-Assembly, and Syringe Sub-Assembly to reduce manufacturing yield loss.

Current openFDA PMA Record#

Device: Mara Water Vapor Ablation System
Applicant: CooperSurgical, Inc.
PMA number: P160047
Supplement: S028
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2023-01-19
Decision code: OK30
Date received: 2022-12-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the manufacturer and manufacturing of the Sleeve Cartridge Sub-Assembly, Outflow Tube Sub-Assembly, and Syringe Sub-Assembly to reduce manufacturing yield loss.