GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Premarket Approval P970021 S044

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 changes to the gynecare thermachoice iii ubt labels, instructions for use, operating manual, and patient labeling.

DeviceGYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
Classification NameDevice, Thermal Ablation, Endometrial
Generic NameDevice, Thermal Ablation, Endometrial
ApplicantGYNECARE, INC.
Date Received2015-10-06
Decision Date2016-01-04
PMAP970021
SupplementS044
Product CodeMNB
Advisory CommitteeObstetrics/Gynecology
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address GYNECARE, INC. p.o. Box 151 sommerville, NJ 08876-0151

Supplemental Filings

Supplement NumberDateSupplement Type
P970021Original Filing
S044 2015-10-06 Real-time Process
S043 2015-09-02 30-day Notice
S042 2014-11-05 30-day Notice
S041 2014-03-07 Normal 180 Day Track No User Fee
S040 2013-12-18 Real-time Process
S039 2013-12-09 Normal 180 Day Track No User Fee
S038 2013-04-24 Real-time Process
S037 2012-02-23 135 Review Track For 30-day Notice
S036 2011-08-03 Real-time Process
S035 2011-04-08 30-day Notice
S034 2011-03-07 30-day Notice
S033 2011-01-31 30-day Notice
S032 2011-01-20 30-day Notice
S031 2010-10-28 30-day Notice
S030 2010-10-25 135 Review Track For 30-day Notice
S029 2010-08-06 135 Review Track For 30-day Notice
S028 2009-11-20 Normal 180 Day Track No User Fee
S027 2009-05-21 30-day Notice
S026 2009-03-06 Real-time Process
S025 2008-12-16 Real-time Process
S024 2008-12-15 30-day Notice
S023 2008-08-21 30-day Notice
S022 2008-07-25 30-day Notice
S021 2008-07-23 30-day Notice
S020 2008-04-14 30-day Notice
S019 2008-04-14 Real-time Process
S018 2008-04-14 30-day Notice
S017
S016 2007-12-03 Normal 180 Day Track No User Fee
S015 2007-07-13 Real-time Process
S014 2007-01-11 Normal 180 Day Track
S013
S012 2004-12-17 Special (immediate Track)
S011 2004-07-07 Real-time Process
S010 2003-11-18 Normal 180 Day Track No User Fee
S009 2003-06-20 Normal 180 Day Track
S008 2003-01-15 Normal 180 Day Track
S007 2003-01-13 Normal 180 Day Track
S006 2002-11-08 Normal 180 Day Track
S005 2000-08-28 Normal 180 Day Track
S004 2000-08-07 Normal 180 Day Track
S003 2000-03-28 Normal 180 Day Track
S002 1999-02-03 Normal 180 Day Track
S001 1998-02-02 Normal 180 Day Track

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