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Device | NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM |
Generic Name | Device, thermal ablation, endometrial |
Applicant | HOLOGIC, INC. 250 Campus Drive Marlborough, MA 01752 |
PMA Number | P010013 |
Date Received | 02/28/2001 |
Decision Date | 09/28/2001 |
Product Code |
MNB |
Docket Number | 02M-0128 |
Notice Date | 03/28/2002 |
Advisory Committee |
Obstetrics/Gynecology |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE NOVASURE(TM) IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM. THE DEVICE IS INTENDED TO ABLATE THE ENDOMETRIAL LINING OF THE UTERUS OF PRE-MENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S039 S041 S032 S033 S034 S035 S036 S059 S056 S057 S024 S012 S006 S007 S015 S019 S002 S003 S020 S022 S023 S031 S028 S029 S030 S001 S005 S017 S011 S067 S042 S049 S050 S051 S052 S053 S060 S061 S064 S062 S045 S058 S043 S065 S066 S046 S054 S055 S063 S047 S048 S004 S014 S008 S009 S010 S025 S018 S026 S027 S068 S021 S075 S082 S083 S084 S085 S086 S081 S090 S069 S070 S071 S072 S073 S077 S078 S079 S087 S088 S089 S080 S091
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