MINERVA ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P140013/S003 · decided 2016-09-21
Approval details
- PMA number
- P140013
- Supplement
- S003
- Supplement type
- Real-Time Process
- 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
- 2016-07-05
- Decision date
- 2016-09-21
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for the addition of two gas shutoff solenoid valves and the implementation of a thermally bonded manifold module.
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