MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM
FDA premarket approval P020031 · decided 2003-09-23
Approval details
- PMA number
- P020031
- Trade name
- MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Microsulis Medical , Ltd.
- Date received
- 2002-07-24
- Decision date
- 2003-09-23
- Days to decision
- 426 days
- Decision code
- APWD
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Denmead Hampshire
- Statement
- APPROVAL FOR THE MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM. THE DEVICE IS INDICATED FOR ABLATION OF THE ENDOMETRIAL LINING OF THE UTERUS IN PRE-MENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE UTERINE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE.
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