PMA P010013S063
- Device
- NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S063
- Product code
- MNB
- Decision date
- 2015-06-15
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: TO INCREASE IN NUMBER OF STUDY SITES.
Current openFDA PMA Record#
- Device
- NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S063
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2015-06-15
- Decision code
- APPR
- Date received
- 2015-04-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE: TO INCREASE IN NUMBER OF STUDY SITES.