NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P010013/S021 · decided 2009-02-04
Approval details
- PMA number
- P010013
- Supplement
- S021
- Supplement type
- Real-Time Process
- 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
- 2008-12-09
- Decision date
- 2009-02-04
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR CHANGES TO THE RF CONTROLLER MACHINE LOGIC TO SIMPLIFY PROGRAMMING AND MINOR ERGONOMIC IMPROVEMENTS.
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