NovaSure Impedance Controlled Endometrial Ablation System
FDA premarket approval P010013/S081 · decided 2021-06-30
Approval details
- PMA number
- P010013
- Supplement
- S081
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NovaSure Impedance Controlled Endometrial Ablation System
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Hologic, Inc.
- Date received
- 2020-12-02
- Decision date
- 2021-06-30
- Days to decision
- 210 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- Approval for design modifications of the cervical collar tip and the liner, addition of marking to the external sheath, change in color of front grip handle, new logo and tag, and labeling modifications.
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