NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P010013/S014 · decided 2005-07-22
Approval details
- PMA number
- P010013
- Supplement
- S014
- Supplement type
- Real-Time Process
- 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
- 2005-05-12
- Decision date
- 2005-07-22
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR A MODIFICATION TO THE DEVICE PERFORMANCE PROTOCOL USED TO ESTABLISH THE SHELF LIFE OF THE NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM. THE PROTOCOL USED TO ASSESS PACKAGE INTEGRITY, I.E., PPQ-012, PREVIOUSLY APPROVED IS UNCHANGED.)
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