PMA P010013S078
- Device
- Novasure Impedance Controlled Endometrial Ablation System
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S078
- Product code
- MNB
- Decision date
- 2019-10-01
- Classification
- Device, Thermal Ablation, Endometrial
- Generic name
- Device, thermal ablation, endometrial
- Approval order statement
- Replace a Stoll CMS 340 knitting machine with a Stoll CMS 822 knitting machine.
Current openFDA PMA Record#
- Device
- Novasure Impedance Controlled Endometrial Ablation System
- Applicant
- Hologic, Inc.
- PMA number
- P010013
- Supplement
- S078
- Product code
- MNB
- Generic name
- Device, thermal ablation, endometrial
- Decision date
- 2019-10-01
- Decision code
- OK30
- Date received
- 2019-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace a Stoll CMS 340 knitting machine with a Stoll CMS 822 knitting machine.