LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Premarket Approval P000008 S014

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 modifying the labeling to identify the ¿pars flaccida¿ technique as the recommended technique to use during surgical placement of the device.

DeviceLAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
Classification NameImplant, Intragastric For Morbid Obesity
Generic NameImplant, Intragastric For Morbid Obesity
ApplicantReShape Lifesciences, Inc.
Date Received2008-12-18
Decision Date2009-01-16
PMAP000008
SupplementS014
Product CodeLTI
Docket NumberPremarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radia
Advisory CommitteeGastroenterology/Urology
Supplement TypeSpecial (immediate Track)
Supplement ReasonChange Design/components/specifications/material
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

NIH GUDID Devices

Device IDPMASupp
00850007764173 P000008 000
10850007764323 P000008 000
10850007764330 P000008 000
00850007764906 P000008 000
00850007764609 P000008 029
00850007764067 P000008 029
00850007764043 P000008 029
00850007764654 P000008 029
00850007764517 P000008 048
00850007764548 P000008 048
00850007764555 P000008 048
00850007764586 P000008 048
00850007764500 P000008 048

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