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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameHER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal (cryosurgical) endometrial ablation device
ApplicantCOOPERSURGICAL, INC.
PMA NumberP000032
Date Received07/27/2000
Decision Date04/20/2001
Product Code
MNB
Docket Number 01M-0412
Notice Date 09/24/2001
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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 
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