|
Device | MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | MICROSULIS MEDICAL LTD. PARKLANDS BUSINESS PARK DENMEAD HAMPSHIRE PO7 6 |
PMA Number | P020031 |
Date Received | 07/24/2002 |
Decision Date | 09/23/2003 |
Withdrawal Date
|
07/05/2011 |
Product Code |
MNB |
Docket Number | 04M-0031 |
Notice Date | 01/22/2004 |
Advisory Committee |
Obstetrics/Gynecology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 |