Minerva Endometrial Ablation System
FDA premarket approval P140013/S007 · decided 2017-06-26
Approval details
- PMA number
- P140013
- Supplement
- S007
- 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
- 2017-04-03
- Decision date
- 2017-06-26
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for software changes to the Minerva Endometrial Ablation System (i.e., software modifications to 1) correct an error code during device start; 2) to redefine existing error codes to better align them with the observed device conditions; and 3) to add five software checks to the device).
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