NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P010013/S065 · decided 2015-10-15
Approval details
- PMA number
- P010013
- Supplement
- S065
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Hologic, Inc.
- Date received
- 2015-08-17
- Decision date
- 2015-10-15
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY TO REFLECT THE FDA APPROVAL OF THE USE OF TRANSVAGINAL ULTRASOUND (TVU) AS AN ALTERNATE CONFIRMATION TEST FOR ESSURE.
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