HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P000040/S005 · decided 2005-07-12
Approval details
- PMA number
- P000040
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2005-06-20
- Decision date
- 2005-07-12
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR MANUFACTURING PROCESS AND QUALITY CONTROL CHANGES TO THE ADAPTERS USED TO CONNECT A HYSTEROSCOPE TO THE HTA SYSTEM PROCEDURE SHEATH.
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