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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceHER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantCooperSurgical, Inc.
95 Corporate Dr.
Trumbull, CT 06611
PMA NumberP000032
Date Received07/27/2000
Decision Date04/20/2001
Withdrawal Date 09/07/2023
Product Code MNB 
Docket Number 01M-0412
Notice Date 09/24/2001
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE HEROPTION(TM) UTERINE CRYOBLATION THERAPY(TM) SYSTEM. THE DEVICE IS A CLOSED-CYCLE CRYOSURGICAL DEVICE INTENDED TO ABLATE THE ENDOMETRIAL LINING OF THE UTERUS IN PRE-MENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S003 S004 S005 S006 S008 S009 S011 S012 S013 S016 
S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 
S041 S042 S043 
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