PMA P010013S060
- Device
- NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S060
- Product code
- MNB
- Decision date
- 2014-10-06
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- UPDATE ON MANUFACTURING PROCEDURE TO REDUCE SCRAP AT THE WORK STATION.
Current openFDA PMA Record#
- Device
- NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S060
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2014-10-06
- Decision code
- OK30
- Date received
- 2014-09-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPDATE ON MANUFACTURING PROCEDURE TO REDUCE SCRAP AT THE WORK STATION.