HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Premarket Approval P000032

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.

Pre-market Approval Supplement Details

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.

DeviceHER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM
Classification NameDevice, Thermal Ablation, Endometrial
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantCooperSurgical, Inc.
Date Received2000-07-27
Decision Date2001-04-20
Notice Date2001-09-24
PMAP000032
SupplementS
Product CodeMNB
Docket Number01M-0412
Advisory CommitteeObstetrics/Gynecology
Expedited ReviewNo
Combination Product No
Applicant Address CooperSurgical, Inc. 95 Corporate Dr. trumbull, CT 06611
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P000032Original Filing
S043 2017-12-12 Normal 180 Day Track
S042 2014-11-24 30-day Notice
S041 2013-06-17 30-day Notice
S040 2013-02-08 30-day Notice
S039 2013-02-08 30-day Notice
S038 2012-08-23 Normal 180 Day Track No User Fee
S037 2011-10-03 Normal 180 Day Track No User Fee
S036 2011-07-25 Normal 180 Day Track No User Fee
S035 2010-01-26 30-day Notice
S034 2010-01-25 30-day Notice
S033 2010-01-22 135 Review Track For 30-day Notice
S032 2010-01-21 135 Review Track For 30-day Notice
S031 2009-12-11 30-day Notice
S030 2009-11-23 Real-time Process
S029 2009-10-02 30-day Notice
S028 2008-06-06 Normal 180 Day Track
S027 2008-04-25 30-day Notice
S026 2008-03-18 30-day Notice
S025 2008-02-06 135 Review Track For 30-day Notice
S024 2008-01-09 30-day Notice
S023 2007-11-27 30-day Notice
S022 2007-10-17 135 Review Track For 30-day Notice
S021 2007-06-28 30-day Notice
S020 2006-05-17 135 Review Track For 30-day Notice
S019 2006-05-12 135 Review Track For 30-day Notice
S018 2006-03-31 135 Review Track For 30-day Notice
S017 2006-01-17 Special (immediate Track)
S016 2006-01-11 30-day Notice
S015
S014
S013 2005-08-13 Normal 180 Day Track
S012 2005-08-04 Real-time Process
S011 2005-06-09 30-day Notice
S010
S009 2005-05-02 30-day Notice
S008 2005-03-31 30-day Notice
S007
S006 2005-02-24 30-day Notice
S005 2004-01-20 Normal 180 Day Track No User Fee
S004 2003-12-08 Normal 180 Day Track No User Fee
S003 2003-04-24 Normal 180 Day Track No User Fee
S002
S001 2001-08-09 Special (immediate Track)

NIH GUDID Devices

Device IDPMASupp
20888937000027 P000032 000
00888937000016 P000032 000

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