HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM
FDA premarket approval P000040 · decided 2001-04-20
Approval details
- PMA number
- P000040
- Trade name
- HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Axora Medical, Inc.
- Date received
- 2000-09-25
- Decision date
- 2001-04-20
- Days to decision
- 207 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR THE HYDRO THERMABLATOR(R) ENDOMETRIAL ABLATION SYSTEM. THE DEVICE IS INTENDED TO ABLATE THE ENDOMETRIAL LINING OF THE UTERUS IN PREMENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE UTERINE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILD BEARING IS COMPLETE.
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