LAP-BAND System

Implant, Intragastric For Morbid Obesity

FDA Premarket Approval P000008 S047

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 updates to three lap-band® system directions for use and the surgical aid instructions with a change of the initial post-operative band fluid volume adjustment period to four weeks post-implantation.

DeviceLAP-BAND System
Classification NameImplant, Intragastric For Morbid Obesity
Generic NameImplant, Intragastric For Morbid Obesity
ApplicantReShape Lifesciences, Inc.
Date Received2019-07-24
Decision Date2019-11-13
PMAP000008
SupplementS047
Product CodeLTI
Advisory CommitteeGastroenterology/Urology
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address ReShape Lifesciences, Inc. 100 Calle Amanecer san Clemente, CA 92672

Supplemental Filings

Supplement NumberDateSupplement Type
P000008Original Filing
S047 2019-07-24 Real-time Process
S046 2018-12-19 30-day Notice
S045 2018-12-18 135 Review Track For 30-day Notice
S044 2018-09-24 30-day Notice
S043 2018-06-25 30-day Notice
S042 2018-01-16 30-day Notice
S041 2017-12-15 30-day Notice
S040 2017-12-15 30-day Notice
S039 2017-07-05 Normal 180 Day Track No User Fee
S038 2017-02-15 30-day Notice
S037 2016-01-29 Normal 180 Day Track No User Fee
S036 2015-12-21 Normal 180 Day Track No User Fee
S035 2015-10-26 Normal 180 Day Track No User Fee
S034 2015-07-06 Normal 180 Day Track No User Fee
S033 2015-01-29 Normal 180 Day Track No User Fee
S032 2014-10-06 Special (immediate Track)
S031 2013-04-18 Normal 180 Day Track No User Fee
S030 2013-03-05 30-day Notice
S029 2012-09-13 Normal 180 Day Track No User Fee
S028 2012-06-01 Normal 180 Day Track
S027 2012-02-29 Normal 180 Day Track
S026 2011-10-11 Real-time Process
S025
S024 2011-07-14 Special (immediate Track)
S023 2011-03-18 Normal 180 Day Track No User Fee
S022 2011-03-18 Normal 180 Day Track No User Fee
S021 2010-10-12 30-day Notice
S020 2010-09-16 Special (immediate Track)
S019 2010-07-02 Normal 180 Day Track No User Fee
S018 2010-05-21 Special (immediate Track)
S017 2010-04-27 Panel Track
S016
S015
S014 2008-12-18 Special (immediate Track)
S013 2008-04-07 135 Review Track For 30-day Notice
S012 2008-02-28 Normal 180 Day Track
S011
S010 2006-10-03 Normal 180 Day Track No User Fee
S009 2005-10-26 Normal 180 Day Track
S008 2005-08-09 Normal 180 Day Track
S007
S006 2003-06-05 Normal 180 Day Track
S005 2002-11-21 Normal 180 Day Track
S004 2002-03-14 Normal 180 Day Track
S003 2002-03-13 Normal 180 Day Track
S002 2002-01-24 Normal 180 Day Track
S001 2002-01-11 Normal 180 Day Track

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