PMA P010013S084
- Device
- NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S084
- Product code
- MNB
- Decision date
- 2021-08-30
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Change in supplier of NovaSure mechanism components, ASY-02797 (NovaSure Gen 3) and ASY-09341 (NovaSure Gen 4.1 & V5).
Current openFDA PMA Record#
- Device
- NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S084
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2021-08-30
- Decision code
- OK30
- Date received
- 2021-08-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in supplier of NovaSure mechanism components, ASY-02797 (NovaSure Gen 3) and ASY-09341 (NovaSure Gen 4.1 & V5).