HYDRO THERMABLATOR. ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P000040/S002 · decided 2001-12-07
Approval details
- PMA number
- P000040
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HYDRO THERMABLATOR. ENDOMETRIAL ABLATION SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2001-10-09
- Decision date
- 2001-12-07
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR USING MOLDING AND EXTRUDING TECHNIQUES RATHER THAN MACHINING THE COMPONENTS THAT NMAKE UP THE DISPOSABLE SHEATH OF THE HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM.
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