PMA P010013S094
- Device
- NovaSure Model 10 RF Controller
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S094
- Product code
- MNB
- Decision date
- 2025-12-17
- Classification
- Obstetrics/Gynecology
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- a new supplier of the LCD screen
Current openFDA PMA Record#
- Device
- NovaSure Model 10 RF Controller
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S094
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2025-12-17
- Decision code
- OK30
- Date received
- 2025-12-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new supplier of the LCD screen