PMA P010013S079
- Device
- NovaSure Impedance Controlled Endometrial Ablation System
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S079
- Product code
- MNB
- Decision date
- 2020-10-19
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Add an additional supplier of deionized water used in the manufacture of the Novosure device.
Current openFDA PMA Record#
- Device
- NovaSure Impedance Controlled Endometrial Ablation System
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S079
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2020-10-19
- Decision code
- OK30
- Date received
- 2020-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an additional supplier of deionized water used in the manufacture of the Novosure device.