NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P010013/S026 · decided 2010-01-12
Approval details
- PMA number
- P010013
- Supplement
- S026
- 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
- 2009-11-13
- Decision date
- 2010-01-12
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR THE ADDITION OF SMOOTH ACCESS TIPS TO THE TIPS OF THE NOVASURE DISPOSABLE ARRAY.
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