|
Device | MAESTRO RECHARGEABLE SYSTEM |
Generic Name | neuromodulator for obesity |
Applicant | ReShape Lifesciences, Inc. 2800 PATTON ROAD SAINT PAUL, MN 55113 |
PMA Number | P130019 |
Date Received | 06/21/2013 |
Decision Date | 01/14/2015 |
Withdrawal Date
|
01/19/2021 |
Product Code |
PIM |
Docket Number | 15M-0201 |
Notice Date | 01/16/2015 |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT01327976
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 |