Minerva Endometrial Ablation System
FDA premarket approval P140013/S015 · decided 2024-01-24
Approval details
- PMA number
- P140013
- Supplement
- S015
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Minerva Endometrial Ablation System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2024-01-03
- Decision date
- 2024-01-24
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for an update to a manufacturing procedure to provide an additional requirement for the silicone tubing for the Minerva ES Handpiece.
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