MINERVA ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P140013/S005 · decided 2017-05-15
Approval details
- PMA number
- P140013
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MINERVA ENDOMETRIAL ABLATION SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2016-10-04
- Decision date
- 2017-05-15
- Days to decision
- 223 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for the addition of a CO2 extension tube and sheath marking to the Minerva Handpiece and software modifications to the gas management module in the RF controller.
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