Minerva Endometrial Ablation System
FDA premarket approval P140013/S016 · decided 2025-04-14
Approval details
- PMA number
- P140013
- Supplement
- S016
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Minerva Endometrial Ablation System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2024-10-04
- Decision date
- 2025-04-14
- Days to decision
- 192 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- 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
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