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Device | HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | Minerva Surgical, Inc. 4255 Burton Drive Santa Clara, CA 95054 |
PMA Number | P000040 |
Supplement Number | S004 |
Date Received | 08/25/2003 |
Decision Date | 02/24/2004 |
Product Code |
MNB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR UPDATED LABELING THAT REFLECTS THE 2 AND 3 YEAR PATIENT FOLLOW-UP DATA. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HTZ SYSTEM AND IS INDICATED FOR ABLATION OF THE ENDOMETRIAL LINING OF THE UTERUS IN PREMENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE UTERINE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE. |