GENESYS HTA SYSTEM
FDA premarket approval P000040/S014 · decided 2010-04-23
Approval details
- PMA number
- P000040
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GENESYS HTA SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2009-05-06
- Decision date
- 2010-04-23
- Days to decision
- 352 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR THE ¿NEXT GENERATION¿ HTA SYSTEM WITH A REDESIGNED OPERATIONAL UNIT (CONTROL UNIT, POWER CORD, PEDESTAL, IV POLE) AND A MODIFIED STERILE PROCEDURE SET. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GENESYS HTA SYSTEM AND IS INDICATED FOR ABLATION OF THE ENDOMETRIAL LINING OF THE UTERUS IN PREMENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE UTERINE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE.
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