MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM
FDA premarket approval P020031/S002 · decided 2005-10-14
Approval details
- PMA number
- P020031
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Microsulis Medical , Ltd.
- Date received
- 2005-07-12
- Decision date
- 2005-10-14
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Denmead Hampshire
- Statement
- APPROVAL FOR REVISED PATIENT LABELING.
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