|
Device | Obalon Balloon System with Navigation Touch |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | ReShape Lifesciences, Inc. 1001 Calle Amanecer San Clemente, CA 92673 |
PMA Number | P160001 |
Supplement Number | S020 |
Date Received | 07/31/2018 |
Decision Date | 12/20/2018 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT03497910
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the use of the Obalon Navigation-Touch System for administration of the Obalon Balloon System. |
Post-Approval Study | Show Report Schedule and Study Progress |