HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P000040/S009 · decided 2007-03-23
Approval details
- PMA number
- P000040
- Supplement
- S009
- Supplement type
- Real-Time Process
- 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
- 2006-11-07
- Decision date
- 2007-03-23
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL TO INCLUDE CLEANING, STERILIZATION AND REUSE INSTRUCTIONS FOR THE HTA SYSTEM SCOPE ADAPTORS IN A NEW PACKAGE INSERT AND IN THE HTA SYSTEM USER?S MANUAL.
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