This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the maestro® rechargeable system. This device is indicated for use in weight reduction in patients aged 18 years through adulthood who have a body mass index (bmi) of 40 to 45 kg/m2, or a bmi of 35 to 39. 9 kg/m2 with one or more obesity related co-morbid conditions, and have failed at least one supervised weight management program within the past five years.
| Device | MAESTRO RECHARGEABLE SYSTEM |
| Classification Name | Neuromodulator For Obesity |
| Generic Name | Neuromodulator For Obesity |
| Applicant | ReShape Lifesciences, Inc. |
| Date Received | 2013-06-21 |
| Decision Date | 2015-01-14 |
| Notice Date | 2015-01-16 |
| PMA | P130019 |
| Supplement | S |
| Product Code | PIM |
| Docket Number | 15M-0201 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ReShape Lifesciences, Inc. 2800 Patton Road saint Paul, MN 55113 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130019 | Original Filing | |
| S019 | 2018-12-17 | Normal 180 Day Track No User Fee |
| S018 | 2018-02-12 | Real-time Process |
| S017 | 2018-02-09 | Real-time Process |
| S016 | 2017-12-28 | 30-day Notice |
| S015 | 2017-06-08 | Normal 180 Day Track No User Fee |
| S014 | 2017-04-28 | Real-time Process |
| S013 | 2017-03-02 | Special (immediate Track) |
| S012 | 2016-12-08 | Special (immediate Track) |
| S011 | 2016-09-29 | Real-time Process |
| S010 | 2016-08-26 | 30-day Notice |
| S009 | 2016-06-07 | Normal 180 Day Track No User Fee |
| S008 | 2016-05-13 | 30-day Notice |
| S007 | 2016-01-20 | 30-day Notice |
| S006 | 2015-03-25 | Real-time Process |
| S005 | 2015-03-24 | Real-time Process |
| S004 | 2015-03-23 | 30-day Notice |
| S003 | 2015-03-20 | 30-day Notice |
| S002 | 2015-02-27 | Normal 180 Day Track No User Fee |
| S001 | 2015-02-26 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 00857334004361 | P130019 | 000 |
| 00857334004200 | P130019 | 000 |
| 00857334004217 | P130019 | 000 |
| 00857334004248 | P130019 | 000 |
| 00857334004262 | P130019 | 000 |
| 00857334004279 | P130019 | 000 |
| 00857334004286 | P130019 | 000 |
| 00857334004293 | P130019 | 000 |
| 00857334004309 | P130019 | 000 |
| 00857334004316 | P130019 | 000 |
| 00857334004323 | P130019 | 000 |
| 00857334004347 | P130019 | 000 |
| 00857334004354 | P130019 | 000 |
| 00857334004194 | P130019 | 000 |