NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P010013/S067 · decided 2017-01-10
Approval details
- PMA number
- P010013
- Supplement
- S067
- 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
- 2016-08-01
- Decision date
- 2017-01-10
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- Approval for design modifications to the NovaSure Disposable Device (Gen 4.1).
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