|
Device | Maestro Rechargeable System |
Generic Name | neuromodulator for obesity |
Applicant | ReShape Lifesciences, Inc. 2800 PATTON ROAD SAINT PAUL, MN 55113 |
PMA Number | P130019 |
Supplement Number | S019 |
Date Received | 12/17/2018 |
Decision Date | 02/15/2019 |
Withdrawal Date
|
01/19/2021 |
Product Code |
PIM |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT01327976
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the revised protocol which includes modification to the follow-up schedule for the post-approval study (PAS) protocol. |