Minerva Genesys HTA Endometrial Ablation System
FDA premarket approval P000040/S041 · decided 2021-06-17
Approval details
- PMA number
- P000040
- Supplement
- S041
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Minerva Genesys HTA Endometrial Ablation System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2021-05-20
- Decision date
- 2021-06-17
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for a manufacturing site change to your new facility located at Apical Instruments, Inc, 2971 Spring Street, Redwood City, CA 94063. The facility operations at this site will involve the manufacturing of the Minerva Genesys HTA Controller.
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