HTA SYSTEM
FDA premarket approval P000040/S011 · decided 2007-07-16
Approval details
- PMA number
- P000040
- Supplement
- S011
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HTA SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2007-06-12
- Decision date
- 2007-07-16
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR THE INCLUSION OF ADDITIONAL WARNINGS AND PRECAUTIONS TO MINIMIZE BURN INJURIES AND TO ENSURE PROPER HANDLING OF THE PROCEDURE SHEATH.
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