Approval of the revised protocol which includes modification to the follow-up schedule for the post-approval study (pas) protocol.
| Device | Maestro Rechargeable System |
| Classification Name | Neuromodulator For Obesity |
| Generic Name | Neuromodulator For Obesity |
| Applicant | ReShape Lifesciences, Inc. |
| Date Received | 2018-12-17 |
| Decision Date | 2019-02-15 |
| PMA | P130019 |
| Supplement | S019 |
| Product Code | PIM |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ReShape Lifesciences, Inc. 2800 Patton Road saint Paul, MN 55113 |
Supplemental Filings
| 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 |
NIH GUDID Devices