PMA P010013S085
- Device
- NovaSure Impedance Controlled Endometrial Ablation System
- Applicant
- Hologic, Inc.
- Product code
- MNB
- Decision date
- 2022-01-04
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Approval for a revision to the NovaSure post approval study protocol, S0112003.
Current openFDA PMA Record#
- Device
- NovaSure Impedance Controlled Endometrial Ablation System
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S085
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2022-01-04
- Decision code
- APPR
- Date received
- 2021-10-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for a revision to the NovaSure post approval study protocol, S0112003.