Minerva ES Endometrial Ablation System
FDA premarket approval P140013/S017 · decided 2024-12-05
Approval details
- PMA number
- P140013
- Supplement
- S017
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Minerva ES Endometrial Ablation System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2024-11-12
- Decision date
- 2024-12-05
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- approval for a process change to reduce occurrence of error codes that may occur during device use and labeling changes to clarify troubleshooting steps
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