Obalon Balloon System

FDA Premarket Approval P160001 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

DeviceObalon Balloon System
Generic NameImplant, Intragastric For Morbid Obesity
ApplicantReShape Lifesciences, Inc.1001 Calle Amanecersan Clemente, CA 92673 PMA NumberP160001 Supplement NumberS047 Date Received01/19/2022 Decision Date07/18/2022 Product Code LTI  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
Date Received2022-01-19
Decision Date2022-07-18
PMAP160001
SupplementS047
Product CodeLTI 
Advisory CommitteeGastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination ProductNo
Applicant AddressReShape Lifesciences, Inc.
1001 Calle Amanecer
san Clemente, CA 92673 PMA NumberP160001 Supplement NumberS047 Date Received01/19/2022 Decision Date07/18/2022 Product Code LTI  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No Combination ProductNo Approval Order Statement  
This Original PMA Was Approved On 9/8/2016 And The Supplement S003 Was Approved On April 25, 2017.

Supplemental Filings

Supplement NumberDateSupplement Type
P160001Original Filing
S047 2022-01-19 Normal 180 Day Track No User Fee
S046 2020-03-02 Special (immediate Track)
S045
S044 2019-11-13 Real-time Process
S043 2019-07-02 30-day Notice
S042 2019-06-14 Normal 180 Day Track No User Fee
S041 2019-06-03 30-day Notice
S040 2019-06-03 30-day Notice
S039
S038 2019-04-19 Normal 180 Day Track No User Fee
S037 2019-04-19 30-day Notice
S036 2019-03-29 30-day Notice
S035 2019-03-18 30-day Notice
S034
S033
S032 2019-01-31 30-day Notice
S031
S030 2019-01-18 Special (immediate Track)
S029 2018-11-19 30-day Notice
S028 2018-10-23 30-day Notice
S027 2018-10-15 Real-time Process
S026 2018-10-15 30-day Notice
S025 2018-10-11 30-day Notice
S024 2018-10-11 30-day Notice
S023 2018-09-18 30-day Notice
S022 2018-09-06 30-day Notice
S021 2018-09-05 Normal 180 Day Track No User Fee
S020 2018-07-31 Normal 180 Day Track
S019 2018-06-12 30-day Notice
S018 2018-05-16 Normal 180 Day Track No User Fee
S017 2018-05-14 30-day Notice
S016 2018-05-03 30-day Notice
S015 2018-04-23 Real-time Process
S014 2018-04-11 30-day Notice
S013 2018-02-21 Special (immediate Track)
S012
S011 2018-01-10 135 Review Track For 30-day Notice
S010 2018-01-04 30-day Notice
S009 2018-01-04 30-day Notice
S008 2018-01-04 135 Review Track For 30-day Notice
S007 2017-11-01 Normal 180 Day Track
S006
S005 2017-03-02 Special (immediate Track)
S004
S003 2016-11-16 Normal 180 Day Track
S002 2016-11-16 30-day Notice
S001 2016-10-14 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
10859810006002 P160001 000
10859810006057 P160001 000
00859810006043 P160001 000
00859810006036 P160001 000
10859810006217 P160001 000
00859810006029 P160001 000
10859810006019 P160001 000
00859810006067 P160001 003
00859810006074 P160001 003
20859810006085 P160001 003
00859810006104 P160001 007
00859810006142 P160001 007
00859810006173 P160001 007
00859810006203 P160001 007
00859810006180 P160001 020
00859810006197 P160001 020
10859810006224 P160001 020
00859810006234 P160001 020
00859810006241 P160001 020

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