MINERVA ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P140013/S002 · decided 2016-08-30
Approval details
- PMA number
- P140013
- Supplement
- S002
- 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
- 2016-04-08
- Decision date
- 2016-08-30
- Days to decision
- 144 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for a manufacturing site located at Minnetronix, Inc., 1635 Energy Park, Saint Paul, Minnesota, as a new manufacturing facility.
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