PMA P140013S004
- Device
- MINERVA ENDOMETRIAL ABLATION SYSTEM
- Applicant
- Axora Medical, Inc.
- PMA number
- P140013
- Supplement
- S004
- Product code
- MNB
- Decision date
- 2016-11-09
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for a contract manufacturing site located at Apical Instruments, Redwood City, California.
Current openFDA PMA Record#
- Device
- MINERVA ENDOMETRIAL ABLATION SYSTEM
- Applicant
- Axora Medical, Inc.
- PMA number
- P140013
- Supplement
- S004
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2016-11-09
- Decision code
- APPR
- Date received
- 2016-09-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a contract manufacturing site located at Apical Instruments, Redwood City, California.