MINERVA ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P140013/S004 · decided 2016-11-09
Approval details
- PMA number
- P140013
- Supplement
- S004
- 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
- 2016-09-20
- Decision date
- 2016-11-09
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for a contract manufacturing site located at Apical Instruments, Redwood City, California.
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