MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA)
FDA premarket approval P020031/S003 · decided 2008-09-02
Approval details
- PMA number
- P020031
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA)
- Generic name
- Device, thermal ablation, endometrial
- Applicant
- Microsulis Medical , Ltd.
- Date received
- 2008-04-11
- Decision date
- 2008-09-02
- Days to decision
- 144 days
- Decision code
- APPR
- Product code
- MNB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Denmead Hampshire
- Statement
- APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE FOR THE MEA SYSTEM TO INCLUDE THE RESULTS OF THE LONG-TERM FOLLOW-UP OF STUDY SUBJECTS.
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