Minerva® Endometrial Ablation System
FDA premarket approval P140013/S013 · decided 2022-01-11
Approval details
- PMA number
- P140013
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Minerva® Endometrial Ablation System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2021-12-23
- Decision date
- 2022-01-11
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Transfer of the manifold assembly from the supplier to the contract manufacturer.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.