NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM, & WITH SURESOUND ULTRINE SOUND, NOVASURE RF CONTROLLER 115V
FDA premarket approval P010013/S046 · decided 2013-07-10
Approval details
- PMA number
- P010013
- Supplement
- S046
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM, & WITH SURESOUND ULTRINE SOUND, NOVASURE RF CONTROLLER 115V
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Hologic, Inc.
- Date received
- 2013-06-13
- Decision date
- 2013-07-10
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- MANUFACTURING PROCESS CHANGE FOR ONE OF THE NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM COMPONENTS.
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