HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P000040/S006 · decided 2005-09-21
Approval details
- PMA number
- P000040
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2005-07-18
- Decision date
- 2005-09-21
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR THE ADDITION OF THE TENACULUM STABILIZER COMPONENT TO THE HTA PROCEDURE SET AND FOR CHANGES TO THE PACKAGING, SHELF-LIFE AND LABELING ASSOCIATED WITH THE ADDITION OF THE COMPONENT.
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