PMA P010013S067
- Device
- NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S067
- Product code
- MNB
- Decision date
- 2017-01-10
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for design modifications to the NovaSure Disposable Device (Gen 4.1).
Current openFDA PMA Record#
- Device
- NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S067
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2017-01-10
- Decision code
- APPR
- Date received
- 2016-08-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design modifications to the NovaSure Disposable Device (Gen 4.1).