|
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 | S012 |
Date Received | 12/08/2016 |
Decision Date | 12/22/2016 |
Withdrawal Date
|
01/19/2021 |
Product Code |
PIM |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to updated the Clinician Programmer (CP) build verification procedure to include a specific instructional step to ensure that the internet upload capability feature has been disabled. |