Approval for a design change in the proximal luer hub and subsequent supplier change.
| Device | Obalon Balloon Kit |
| Classification Name | Implant, Intragastric For Morbid Obesity |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | OBALON THERAPEUTICS, INC. |
| Date Received | 2018-04-23 |
| Decision Date | 2018-06-22 |
| PMA | P160001 |
| Supplement | S015 |
| Product Code | LTI |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OBALON THERAPEUTICS, INC. 5421 Avenida Encinas suite F carlsbad, CA 92008 |
Supplemental Filings
| 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 |
NIH GUDID Devices