NOVASURE IMPEDANCE CONTROLLED EDOMETRIAL ABLATION SYSTEM
FDA premarket approval P010013/S058 · decided 2014-10-28
Approval details
- PMA number
- P010013
- Supplement
- S058
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NOVASURE IMPEDANCE CONTROLLED EDOMETRIAL ABLATION SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Hologic, Inc.
- Date received
- 2014-07-27
- Decision date
- 2014-10-28
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR DEVICE MODIFICATIONS, INCLUDING FLATTENING OF THE NVSRAM BATTERY CLIP AND ADDITION OF KAPTON TAPE TO THE NVSRAM BATTERY AND THE UI BOARD SHIELD TO OVERCOME A DEVICE ERROR OCCURRING IF CONTACT OF THESE COMPONENTS OCCURS.
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