Minerva Endometrial Ablation System
FDA premarket approval P140013/S011 · decided 2020-02-12
Approval details
- PMA number
- P140013
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Minerva Endometrial Ablation System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2020-01-13
- Decision date
- 2020-02-12
- Days to decision
- 30 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 Minerva Surgical, 4255 Burton Drive, Santa Clara, California. The facility operations at this site involve the manufacturing of the Minerva Endometrial Ablation System Disposable Handpiece.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.