NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P010013/S042 · decided 2011-12-20
Approval details
- PMA number
- P010013
- Supplement
- S042
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Hologic, Inc.
- Date received
- 2011-11-08
- Decision date
- 2011-12-20
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR A CHANGE TO THE NOVASURE TO ADD THE SURESOUND UTERINE SOUND TO THE EXISTING THERMOFORMED TRAY FOR THE NOVASURE DISPOSABLE DEVICE.
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