NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P010013/S023 · decided 2009-05-08
Approval details
- PMA number
- P010013
- Supplement
- S023
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Hologic, Inc.
- Date received
- 2009-04-08
- Decision date
- 2009-05-08
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR CHANGES INTENDED TO IMPROVE THE INSTRUCTIONS FOR USE IN REGARD TO SAFE REMOVAL OF THE NOVASURE DEVICE FOLLOWING TREATMENT.
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