Minerva Endometrial Ablation System
FDA premarket approval P140013/S006 · decided 2017-08-07
Approval details
- PMA number
- P140013
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Minerva Endometrial Ablation System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2017-02-07
- Decision date
- 2017-08-07
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for labeling changes to update the clinical study results to reflect the final 2- and 3-year follow-up results from the Minerva Single-Arm study, as well as the 1-year follow-up results from the Minerva Randomized Control Trial.
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