HYDRO-THERMABLATOR(HTA) ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P000040/S003 · decided 2003-02-20
Approval details
- PMA number
- P000040
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HYDRO-THERMABLATOR(HTA) ENDOMETRIAL ABLATION SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2003-01-21
- Decision date
- 2003-02-20
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR A REVISED HTA SYSTEM INSTALLATION AND OPERATOR'S MANUAL.
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