PMA P140013S016

Device: Minerva Endometrial Ablation System
Applicant: Axora Medical, Inc.
PMA number: P140013
Supplement: S016
Product code: MNB
Decision date: 2025-04-14
Classification: Obstetrics/Gynecology
Generic name: Device, thermal ablation, endometrial
Approval order statement: approval for a manufacturing site, Scientific Molding Corporation in El Coyol Alajuela, Costa Rica (SMC – Costa Rica), for the Minerva ES Disposable Handpiece for the Minerva Endometrial Ablation System

Current openFDA PMA Record#

Device: Minerva Endometrial Ablation System
Applicant: Axora Medical, Inc.
PMA number: P140013
Supplement: S016
Product code: MNB
Generic name: Device, thermal ablation, endometrial
Decision date: 2025-04-14
Decision code: APPR
Date received: 2024-10-04
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, Scientific Molding Corporation in El Coyol Alajuela, Costa Rica (SMC – Costa Rica), for the Minerva ES Disposable Handpiece for the Minerva Endometrial Ablation System