PMA P010013S077
- Device
- NovaSure Impedance Controlled Endometrial Ablation Device
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S077
- Product code
- MNB
- Decision date
- 2019-09-26
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Change in the amount of antioxidant in the pellethane liner and a change of supplier of black ink used in the pellethane liner.
Current openFDA PMA Record#
- Device
- NovaSure Impedance Controlled Endometrial Ablation Device
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S077
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2019-09-26
- Decision code
- OK30
- Date received
- 2019-09-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the amount of antioxidant in the pellethane liner and a change of supplier of black ink used in the pellethane liner.