PMA P010013S068
- Device
- NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S068
- Product code
- MNB
- Decision date
- 2017-07-18
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Changes to the RF Cable assembly process for the NovaSure disposable device.
Current openFDA PMA Record#
- Device
- NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S068
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2017-07-18
- Decision code
- OK30
- Date received
- 2017-06-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the RF Cable assembly process for the NovaSure disposable device.