PMA P010013S089
- Device
- NovaSure Impedance Controlled Endometrial Ablation System
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S089
- Product code
- MNB
- Decision date
- 2022-12-01
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for the inclusion of updated language to a contraindication in the device instructions for use.
Current openFDA PMA Record#
- Device
- NovaSure Impedance Controlled Endometrial Ablation System
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S089
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2022-12-01
- Decision code
- APPR
- Date received
- 2022-11-02
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the inclusion of updated language to a contraindication in the device instructions for use.