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.
| Device | Obalon Balloon System |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | ReShape 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 Received | 2022-01-19 |
| Decision Date | 2022-07-18 |
| PMA | P160001 |
| Supplement | S047 |
| Product Code | LTI |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ReShape 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. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160001 | Original 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 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 |