PMA P160047S033

Device: MARA Water Vapor Ablation System
Applicant: CooperSurgical, Inc.
PMA number: P160047
Supplement: S033
Product code: MNB
Decision date: 2023-10-25
Classification: Obstetrics/Gynecology
Generic name: Device, thermal ablation, endometrial
Approval order statement: Approval for a modification to the manufacturing process to increase reproducibility of the coil subassembly, balloon subassembly, and MLE subassembly and tail cuts.

Current openFDA PMA Record#

Device: MARA Water Vapor Ablation System
Applicant: CooperSurgical, Inc.
PMA number: P160047
Supplement: S033
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2023-10-25
Decision code: APPR
Date received: 2023-09-26
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a modification to the manufacturing process to increase reproducibility of the coil subassembly, balloon subassembly, and MLE subassembly and tail cuts.