HTA SYSTEM
FDA premarket approval P000040/S013 · decided 2009-05-14
Approval details
- PMA number
- P000040
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HTA SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2009-02-13
- Decision date
- 2009-05-14
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR MODIFICATIONS TO THE HTA PROCEDURE SHEATH (A COMPONENT OF THE HTA SYSTEM) WHICH INCLUDE THE ADDITION OF THE CERVICAL SEAL ASSIST COMPONENT AND A REDESIGN OF THE RESERVOIR TIP. THE SHEATH, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HTA PROCERVA PROCEDURE SHEATH.
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