HER OPTION CYROABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Premarket Approval P000032 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a manufacturing facility located at american medical systems, inc. , minnetonka, minnesota.

DeviceHER OPTION CYROABLATION THERAPY SYSTEM
Classification NameDevice, Thermal Ablation, Endometrial
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantCooperSurgical, Inc.
Date Received2003-12-08
Decision Date2004-03-31
PMAP000032
SupplementS004
Product CodeMNB
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address CooperSurgical, Inc. 95 Corporate Dr. trumbull, CT 06611

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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